# RareDiseaseHedge — State of Bio 2026

> A screen of drugs approved by a foreign regulator (EMA, EEA national registers via
> the EMA Article 57 database, Health Canada, Swissmedic, PMDA) whose active moiety has
> never been approved in the United States. That is the population the FD&C Act
> §529 makes eligible for a rare-pediatric Priority Review Voucher (PRV). Each
> candidate carries a machine-drafted §529 eligibility checklist plus PubMed,
> ClinicalTrials.gov, ChEMBL, Orphadata, EU orphan-designation and FDA complete-response
> signals. Automated agents and AI assistants are welcome to read every page here.

Data snapshot: UNII 4Aug2026 · Drugs@FDA 12 Oct 2026 · Orange Book 12 Oct 2026 · EMA 12 Oct 2026 · Health Canada 12 Oct 2026 · Swissmedic 12 Oct 2026 · PMDA 12 Oct 2026 · GSRS relationship graph
Generated: 2026-10-12

## Headline numbers
- Candidates (approved abroad, never in the US): 338
- Multi-regulator candidates: 22
- Dossier-only (unnamed) rows: 32; rows queued for human review: 9
- Foreign approval rows screened: 18107; of which already in the US record: 2027
- Disclosed PRV sales tracked (SEC 8-K): 36; 2026 range US$ 180.0M–210.0M; record US$ 350.0M (2015)
- Months until the rare-pediatric PRV programme sunset: 35

## Pages
- [Almanac (home)](https://rarediseasehedge.carterpry.com/): searchable shortlist, PRV market charts, pipeline breadth, approval map
- [Candidate table, static HTML](https://rarediseasehedge.carterpry.com/candidates): all candidates in one plain table, no JavaScript needed
- [Full candidate list, plain text](https://rarediseasehedge.carterpry.com/llms-full.txt): one section per candidate incl. the §529 checklist
- [Card-list dashboard](https://rarediseasehedge.carterpry.com/list/): interactive cards with notes export/import
- [Funnel report](https://rarediseasehedge.carterpry.com/funnel): how 18k foreign approval rows narrow to the shortlist
- [Accuracy audit](https://rarediseasehedge.carterpry.com/audit): harness results and known limitations
- [Raw pipeline output, JSON](https://rarediseasehedge.carterpry.com/data/summary.json): everything above, machine-readable

## Notes
- Charts labelled "RDH pipeline" and "SEC 8-K filings" are real data; charts labelled "Illustrative" (disease areas, modalities) are design placeholders.
- Nothing on this site is investment, legal, business or tax advice.


## Candidates (widest EEA reach first)


### Etoricoxib

- Active moiety: ETORICOXIB (UNII WRX4NFY03R)
- Disease: Rheumatic Diseases
- Approved by: EEA national; authorised in 30 EEA countries; status: authorised
- Research activity: 12 PubMed papers, 129 registered trials
- ChEMBL indications: Rheumatic Diseases, Pain, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Osteoarthritis, Knee, Wounds and Injuries
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Fusidic Acid

- Active moiety: FUSIDIC (UNII 59XE10C19C)
- Disease: —
- Approved by: EEA national; authorised in 30 EEA countries; status: authorised
- Research activity: 55 PubMed papers, 27 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Rupatadine

- Active moiety: RUPATADINE (UNII 2AE8M83G3E)
- Disease: Hypersensitivity
- Approved by: EEA national; authorised in 30 EEA countries; status: authorised
- Research activity: 7 PubMed papers, 15 registered trials
- ChEMBL indications: Hypersensitivity, Urticaria, Arthritis, Rheumatoid, Mastocytosis, Cold Urticaria
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Vildagliptin

- Active moiety: VILDAGLIPTIN (UNII I6B4B2U96P)
- Disease: Diabetes Mellitus, Type 2
- Indication: Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:  as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
- Approved by: EMA, EEA national; authorised in 30 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: A10BH02
- Research activity: 0 PubMed papers, 209 registered trials
- ChEMBL indications: Diabetes Mellitus, Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus, Type 1, Glucose Intolerance, Diabetes, Gestational
- US prior filing: APPROVABLE LETTER — NDA (Novartis, type 2 diabetes) · 02/2007
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Alfacalcidol

- Active moiety: ALFACALCIDOL (UNII URQ2517572)
- Disease: Osteoporosis; Muscular Diseases; Osteoporosis, Postmenopausal; Pelvic Organ Prolapse
- Approved by: EEA national, Health Canada; authorised in 29 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 31 PubMed papers, 52 registered trials
- ChEMBL indications: Osteoporosis, Muscular Diseases, Osteoporosis, Postmenopausal, Pelvic Organ Prolapse, Calcinosis, Death, Sudden, Cardiac
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Amorolfine

- Active moiety: AMOROLFINE (UNII AB0BHP2FH0)
- Disease: Onychomycosis
- Approved by: EEA national; authorised in 29 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 13 registered trials
- ChEMBL indications: Onychomycosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bilastine

- Active moiety: BILASTINE (UNII PA1123N395)
- Disease: Eye Manifestations; Hypersensitivity
- Approved by: EEA national, Health Canada; authorised in 29 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 12 PubMed papers, 28 registered trials
- ChEMBL indications: Eye Manifestations, Hypersensitivity, Rhinitis, Allergic, Seasonal, Urticaria, Rhinitis, Allergic, Perennial, Conjunctivitis, Allergic
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Xylometazoline

- Active moiety: XYLOMETAZOLINE (UNII WPY40FTH8K)
- Disease: Eye Manifestations; Nasal Obstruction
- Approved by: EEA national; authorised in 29 EEA countries; status: authorised
- Research activity: 10 PubMed papers, 37 registered trials
- ChEMBL indications: Eye Manifestations, Nasal Obstruction, Common Cold
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'UNAPPROVED DRUG OTHER']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Zuclopenthixol

- Active moiety: ZUCLOPENTHIXOL (UNII 47ISU063SG)
- Disease: Psychotic Disorders; Anxiety; Dementia; Depressive Disorder; Schizophrenia
- Approved by: EEA national, Health Canada; authorised in 29 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 3 PubMed papers, 10 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Benzydamine

- Active moiety: BENZYDAMINE (UNII 4O21U048EF)
- Disease: Rheumatic Diseases; Vaginitis; Arthralgia; Myalgia
- Approved by: EEA national; authorised in 28 EEA countries; status: authorised
- Research activity: 10 PubMed papers, 49 registered trials
- ChEMBL indications: Rheumatic Diseases, Vaginitis, Arthralgia, Myalgia, Stomatitis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bromhexine

- Active moiety: BROMHEXINE (UNII Q1J152VB1P)
- Disease: —
- Approved by: EEA national; authorised in 28 EEA countries; status: authorised
- Research activity: 10 PubMed papers, 30 registered trials
- ChEMBL indications: Malaria
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['EXPORT ONLY']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Moxonidine

- Active moiety: MOXONIDINE (UNII CC6X0L40GW)
- Disease: Hypertension
- Approved by: EEA national; authorised in 28 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 21 registered trials
- ChEMBL indications: Hypertension, Heart Diseases, Hypotension, Orthostatic
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ambroxol

- Active moiety: AMBROXOL (UNII 200168S0CL)
- Disease: Respiratory Tract Diseases; Pharyngitis; Parkinson Disease
- Approved by: EEA national; authorised in 27 EEA countries; status: authorised
- Research activity: 40 PubMed papers, 40 registered trials
- ChEMBL indications: Respiratory Tract Diseases, Pharyngitis, Parkinson Disease, Cough, Dementia, Gaucher Disease
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Etofenamate

- Active moiety: ETOFENAMATE (UNII KZF0XM66JC)
- Disease: —
- Approved by: EEA national; authorised in 27 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Myalgia, Arthralgia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Gliclazide

- Active moiety: GLICLAZIDE (UNII G4PX8C4HKV)
- Disease: Diabetes Mellitus
- Approved by: EEA national, Health Canada; authorised in 27 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 8 PubMed papers, 85 registered trials
- ChEMBL indications: Diabetes Mellitus, Diabetes Mellitus, Type 2, Epilepsy
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Levosimendan

- Active moiety: LEVOSIMENDAN (UNII C6T4514L4E)
- Disease: Heart Failure; ST Elevation Myocardial Infarction; Cardiovascular Diseases; Shock; Amyotrophic Lateral Sclerosis
- Approved by: EEA national; authorised in 27 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 117 PubMed papers, 118 registered trials
- ChEMBL indications: Heart Failure, ST Elevation Myocardial Infarction, Cardiovascular Diseases, Shock, Amyotrophic Lateral Sclerosis, Shock, Septic
- EU orphan designation: Treatment of amyotrophic lateral sclerosis (Withdrawn)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: STEREO_NAME: name carries an enantiomer/racemate marker; check the counterpart's US status by hand
- Note: US_SPONSOR_ACTIVE: Tenax Therapeutics TNX-103 (oral levosimendan, adult PH-HFpEF); Phase 3 LEVEL missed its primary endpoint 2026-08-10, LEVEL-2 ongoing; no NDA. A Tenax approval would bar the moiety for any Funnel-A programme

### Cyproterone

- Active moiety: CYPROTERONE (UNII E61Q31EK2F)
- Disease: —
- Approved by: EEA national; authorised in 26 EEA countries; status: authorised
- Research activity: 33 PubMed papers, 66 registered trials
- ChEMBL indications: Polycystic Ovary Syndrome
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Dapoxetine

- Active moiety: DAPOXETINE (UNII GB2433A4M3)
- Disease: Erectile Dysfunction; Sexual Dysfunction, Physiological; Premature Ejaculation
- Approved by: EEA national; authorised in 26 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 33 registered trials
- ChEMBL indications: Erectile Dysfunction, Sexual Dysfunction, Physiological, Premature Ejaculation
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Mebeverine

- Active moiety: MEBEVERINE (UNII 7F80CC3NNV)
- Disease: Digestive System Diseases
- Approved by: EEA national; authorised in 26 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 20 registered trials
- ChEMBL indications: Digestive System Diseases, Irritable Bowel Syndrome
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Racecadotril

- Active moiety: RACECADOTRIL (UNII 76K53XP4TO)
- Disease: Diarrhea; Diarrhea, Infantile
- Approved by: EEA national; authorised in 26 EEA countries; status: authorised
- Research activity: 23 PubMed papers, 15 registered trials
- ChEMBL indications: Diarrhea, Diarrhea, Infantile
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: STEREO_NAME: name carries an enantiomer/racemate marker; check the counterpart's US status by hand

### Tibolone

- Active moiety: TIBOLONE (UNII FF9X0205V2)
- Disease: Osteoporosis; Sexual Dysfunction, Physiological; Breast Neoplasms; Menopause
- Approved by: EEA national; authorised in 26 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 28 registered trials
- ChEMBL indications: Osteoporosis, Sexual Dysfunction, Physiological, Breast Neoplasms, Menopause, Depressive Disorder, Major
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Cytisinicline

- Active moiety: CYTISINICLINE (UNII 53S5U404NU)
- Disease: Tobacco Use Disorder; Smoking Cessation
- Approved by: EEA national; authorised in 25 EEA countries; status: authorised
- Flags: US filed & refused
- Research activity: 0 PubMed papers, 34 registered trials
- ChEMBL indications: Tobacco Use Disorder, Smoking Cessation, Kidney Diseases
- US prior filing: COMPLETE RESPONSE — NDA 218995 · 06/20/2026
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Fenticonazole

- Active moiety: FENTICONAZOLE (UNII QG05NRB077)
- Disease: —
- Approved by: EEA national; authorised in 25 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Atosiban

- Active moiety: ATOSIBAN (UNII 081D12SI0Z)
- Disease: Obstetric Labor, Premature
- Indication: Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:  regular uterine contractions of at least 30 seconds’ duration at a rate of ? 4 per 30 minutes; a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ? 50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.
- Approved by: EMA, EEA national; authorised in 24 EEA countries; status: authorised
- Flags: multi-regulator
- ATC: G02CX01
- Research activity: 7 PubMed papers, 23 registered trials
- ChEMBL indications: Premature Birth, Endometriosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bromazepam

- Active moiety: BROMAZEPAM (UNII X015L14V0O)
- Disease: Anxiety
- Approved by: EEA national, Health Canada; authorised in 24 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 6 PubMed papers, 5 registered trials
- ChEMBL indications: Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Piracetam

- Active moiety: PIRACETAM (UNII ZH516LNZ10)
- Disease: Attention Deficit Disorder with Hyperactivity
- Approved by: EEA national; authorised in 24 EEA countries; status: authorised
- Research activity: 17 PubMed papers, 16 registered trials
- ChEMBL indications: Attention Deficit Disorder with Hyperactivity, Movement Disorders, Anxiety, Postpoliomyelitis Syndrome, Dementia, Depressive Disorder
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Carbetocin

- Active moiety: CARBETOCIN (UNII 88TWF8015Y)
- Disease: Postpartum Hemorrhage; Prader-Willi Syndrome
- Approved by: EEA national; authorised in 23 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 2 PubMed papers, 103 registered trials
- ChEMBL indications: Postpartum Hemorrhage, Prader-Willi Syndrome, Uterine Inertia, Leiomyoma
- EU orphan designation: Treatment of Prader-Willi syndrome (Withdrawn)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Domperidone

- Active moiety: DOMPERIDONE (UNII 5587267Z69)
- Disease: Digestive System Diseases
- Approved by: EEA national; authorised in 23 EEA countries; status: authorised
- Research activity: 49 PubMed papers, 83 registered trials
- ChEMBL indications: Digestive System Diseases, Gastroparesis, Gastroenteritis, Gastroesophageal Reflux, Dyspepsia, Multiple Sclerosis, Relapsing-Remitting
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Flucloxacillin

- Active moiety: FLUCLOXACILLIN (UNII 43B2M34G2V)
- Disease: —
- Approved by: EEA national; authorised in 23 EEA countries; status: authorised
- Research activity: 62 PubMed papers, 33 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Itopride

- Active moiety: ITOPRIDE (UNII 81BMQ80QRL)
- Disease: Dyspepsia; Peritonitis; Digestive System Diseases
- Approved by: EEA national; authorised in 23 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 33 registered trials
- ChEMBL indications: Dyspepsia, Peritonitis, Digestive System Diseases, Irritable Bowel Syndrome, Constipation, Gastroparesis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Aceclofenac

- Active moiety: ACECLOFENAC (UNII RPK779R03H)
- Disease: Rheumatic Diseases; Myalgia; Arthralgia; Arthritis, Rheumatoid; Spondylitis; Osteoarthritis
- Approved by: EEA national; authorised in 22 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 22 registered trials
- ChEMBL indications: Rheumatic Diseases, Myalgia, Arthralgia, Arthritis, Rheumatoid, Spondylitis, Osteoarthritis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Agomelatine

- Active moiety: AGOMELATINE (UNII 137R1N49AD)
- Disease: Depressive Disorder, Major
- Indication: Treatment of major depressive episodes in adults.
- Approved by: EMA, EEA national; authorised in 22 EEA countries; status: authorised
- Flags: multi-regulator
- ATC: N06AX22
- Research activity: 9 PubMed papers, 27 registered trials
- ChEMBL indications: Depressive Disorder, Major, Depressive Disorder, Anxiety, Dementia, Schizophrenia, Obsessive-Compulsive Disorder
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Trimetazidine

- Active moiety: TRIMETAZIDINE (UNII N9A0A0R9S8)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 22 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 40 registered trials
- ChEMBL indications: Cardiovascular Diseases, Cardiomyopathy, Hypertrophic, Hypertension, Pulmonary, Cardiotoxicity, Diabetic Nephropathies, Non-alcoholic Fatty Liver Disease
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Mianserin

- Active moiety: MIANSERIN (UNII 250PJI13LM)
- Disease: Depressive Disorder
- Approved by: EEA national; authorised in 21 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 5 registered trials
- ChEMBL indications: Depressive Disorder, Anxiety, Dementia, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Carbocysteine

- Active moiety: CARBOCISTEINE (UNII 740J2QX53R)
- Disease: —
- Approved by: EEA national; authorised in 20 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 10 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Iobitridol

- Active moiety: IOBITRIDOL (UNII 182ECH14UH)
- Disease: —
- Approved by: EEA national; authorised in 20 EEA countries; status: authorised
- Research activity: 5 PubMed papers, 9 registered trials
- ChEMBL indications: Acute Kidney Injury
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nitrazepam

- Active moiety: NITRAZEPAM (UNII 9CLV70W7HS)
- Disease: Anxiety; Dementia; Depressive Disorder; Sleep Wake Disorders; Schizophrenia
- Approved by: EEA national; authorised in 20 EEA countries; status: authorised
- Research activity: 20 PubMed papers, 12 registered trials
- ChEMBL indications: Anxiety, Dementia, Depressive Disorder, Sleep Wake Disorders, Schizophrenia, Epilepsy
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sertindole

- Active moiety: SERTINDOLE (UNII GVV4Z879SP)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 20 EEA countries; status: authorised
- Research activity: 9 PubMed papers, 17 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia, Cognitive Dysfunction
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sulthiame

- Active moiety: SULTIAME (UNII I00Q766CZ2)
- Disease: —
- Approved by: EEA national; authorised in 20 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 5 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Diosmin

- Active moiety: DIOSMIN (UNII 7QM776WJ5N)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 19 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 55 registered trials
- ChEMBL indications: Cardiovascular Diseases, Venous Insufficiency, Arthritis, Rheumatoid, Colitis, Ulcerative, Peptic Ulcer, Non-alcoholic Fatty Liver Disease
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED DRUG OTHER']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Ebastine

- Active moiety: EBASTINE (UNII TQD7Q784P1)
- Disease: Hypersensitivity
- Approved by: EEA national; authorised in 19 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 10 registered trials
- ChEMBL indications: Hypersensitivity, Irritable Bowel Syndrome
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Zofenopril

- Active moiety: ZOFENOPRIL (UNII 290ZY759PI)
- Disease: —
- Approved by: EEA national; authorised in 19 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 6 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Hexetidine

- Active moiety: HEXETIDINE (UNII 852A84Y8LS)
- Disease: Infections
- Approved by: EEA national; authorised in 18 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 5 registered trials
- ChEMBL indications: Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Lacidipine

- Active moiety: LACIDIPINE (UNII 260080034N)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 18 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 15 registered trials
- ChEMBL indications: Cardiovascular Diseases, Hypertension, Angina, Stable
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Urapidil

- Active moiety: URAPIDIL (UNII A78GF17HJS)
- Disease: Hypertension; Pre-Eclampsia; Stroke; Cerebrovascular Disorders
- Approved by: EEA national; authorised in 18 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 32 registered trials
- ChEMBL indications: Hypertension, Pre-Eclampsia, Stroke, Cerebrovascular Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Butamirate

- Active moiety: BUTAMIRATE (UNII M75MZG2236)
- Disease: —
- Approved by: EEA national; authorised in 17 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 2 registered trials
- ChEMBL indications: Cough
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Hexamidine

- Active moiety: HEXAMIDINE (UNII 3483C2H13H)
- Disease: Nasal Obstruction; Eye Infections
- Approved by: EEA national; authorised in 17 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 2 registered trials
- ChEMBL indications: Nasal Obstruction, Eye Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['OTC MONOGRAPH DRUG']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Erdosteine

- Active moiety: ERDOSTEINE (UNII 76J0853EKA)
- Disease: Pulmonary Disease, Chronic Obstructive
- Approved by: EEA national; authorised in 16 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 5 PubMed papers, 10 registered trials
- ChEMBL indications: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
- EU orphan designation: Treatment of lead toxicity (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Meldonium

- Active moiety: MELDONIUM (UNII 73H7UDN6EC)
- Disease: —
- Approved by: EEA national; authorised in 16 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 7 registered trials
- ChEMBL indications: Cardiovascular Diseases, Ischemic Stroke
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Moclobemide

- Active moiety: MOCLOBEMIDE (UNII PJ0Y7AZB63)
- Disease: Depressive Disorder
- Approved by: EEA national; authorised in 16 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 9 registered trials
- ChEMBL indications: Depressive Disorder, Anxiety, Dementia, Schizophrenia, Tobacco Use Disorder, Substance-Related Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tramazoline

- Active moiety: TRAMAZOLINE (UNII SLE31693IV)
- Disease: —
- Approved by: EEA national; authorised in 16 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Nasal Obstruction
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bezafibrate

- Active moiety: BEZAFIBRATE (UNII Y9449Q51XH)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 15 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 10 PubMed papers, 27 registered trials
- ChEMBL indications: Cardiovascular Diseases, Hyperlipidemia, Familial Combined, Liver Cirrhosis, Biliary, Cholangitis, Sclerosing, Myelodysplastic Syndromes, Diabetes Mellitus, Type 2
- EU orphan designation: Treatment of primary sclerosing cholangitis (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Octenidine

- Active moiety: OCTENIDINE (UNII OZE0372S5A)
- Disease: —
- Approved by: EEA national; authorised in 15 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 29 registered trials
- ChEMBL indications: Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Roxithromycin

- Active moiety: ROXITHROMYCIN (UNII 21KOF230FA)
- Disease: Bacterial Infections
- Approved by: EEA national; authorised in 15 EEA countries; status: authorised
- Research activity: 31 PubMed papers, 11 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Somatostatin

- Active moiety: SOMATOSTATIN (UNII 6E20216Q0L)
- Disease: Carcinoma, Hepatocellular; Hypertension, Portal; Gallbladder Neoplasms; Neuroendocrine Tumors; Polycystic Kidney, Autosomal Dominant; Pancreatitis
- Approved by: EEA national; authorised in 15 EEA countries; status: authorised
- Flags: US filed & refused
- Research activity: 503 PubMed papers, 359 registered trials
- ChEMBL indications: Carcinoma, Hepatocellular, Hypertension, Portal, Gallbladder Neoplasms, Neuroendocrine Tumors, Polycystic Kidney, Autosomal Dominant, Pancreatitis
- US prior filing: COMPLETE RESPONSE — NDA 208232 · 04/15/2016
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tiapride

- Active moiety: TIAPRIDE (UNII LAH70H9JPH)
- Disease: Anxiety; Dementia; Tourette Syndrome; Psychotic Disorders; Depressive Disorder; Schizophrenia
- Approved by: EEA national; authorised in 15 EEA countries; status: authorised
- Research activity: 11 PubMed papers, 5 registered trials
- ChEMBL indications: Anxiety, Dementia, Tourette Syndrome, Psychotic Disorders, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Benfotiamine

- Active moiety: BENFOTIAMINE (UNII Y92OUS2H9B)
- Disease: Diabetic Neuropathies
- Approved by: EEA national; authorised in 14 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 21 registered trials
- ChEMBL indications: Diabetic Neuropathies, Alzheimer Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Levodropropizine

- Active moiety: LEVODROPROPIZINE (UNII 3O31P6T4G3)
- Disease: Cough; Bronchial Diseases
- Approved by: EEA national; authorised in 14 EEA countries; status: authorised
- Research activity: 9 PubMed papers, 10 registered trials
- ChEMBL indications: Cough, Bronchial Diseases, Dyspnea
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: STEREO_NAME: name carries an enantiomer/racemate marker; check the counterpart's US status by hand

### Lymecycline

- Active moiety: LYMECYCLINE (UNII 7D6EM3S13P)
- Disease: Bacterial Infections
- Approved by: EEA national; authorised in 14 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 6 registered trials
- ChEMBL indications: Bacterial Infections, Acne Vulgaris
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nimesulide

- Active moiety: NIMESULIDE (UNII V4TKW1454M)
- Disease: Rheumatic Diseases; Arthralgia; Myalgia
- Approved by: EEA national; authorised in 14 EEA countries; status: authorised
- Research activity: 34 PubMed papers, 17 registered trials
- ChEMBL indications: Rheumatic Diseases, Arthralgia, Myalgia, Breast Neoplasms, Pain
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Propiverine

- Active moiety: PROPIVERINE (UNII 468GE2241L)
- Disease: Urinary Incontinence; Polyuria
- Approved by: EEA national, Health Canada; authorised in 14 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 15 PubMed papers, 17 registered trials
- ChEMBL indications: Urinary Incontinence, Polyuria, Urinary Bladder, Overactive
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Reboxetine

- Active moiety: REBOXETINE (UNII 947S0YZ36I)
- Disease: Depressive Disorder
- Approved by: EEA national; authorised in 14 EEA countries; status: authorised
- Research activity: 5 PubMed papers, 41 registered trials
- ChEMBL indications: Depressive Disorder, Anxiety, Fibromyalgia, Dementia, Schizophrenia, Fatigue
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Amsacrine

- Active moiety: AMSACRINE (UNII 00DPD30SOY)
- Disease: Neoplasms
- Approved by: EEA national; authorised in 13 EEA countries; status: authorised
- Research activity: 16 PubMed papers, 11 registered trials
- ChEMBL indications: Neoplasms, Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Calcium Dobesilate

- Active moiety: CALCIUM DOBESILATE (UNII 5921X1560Q)
- Disease: Varicose Veins
- Approved by: EEA national; authorised in 13 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 806 registered trials
- ChEMBL indications: Varicose Veins, Menorrhagia, Infertility, Diabetes Mellitus, Type 2, Rosacea
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Propamidine

- Active moiety: PROPAMIDINE (UNII G20G12V769)
- Disease: Acanthamoeba Keratitis; Eye Infections
- Approved by: EEA national; authorised in 13 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 1 registered trials
- ChEMBL indications: Acanthamoeba Keratitis, Eye Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Rilmenidine

- Active moiety: RILMENIDINE (UNII P67IM25ID8)
- Disease: Hypertension
- Approved by: EEA national; authorised in 13 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 2 registered trials
- ChEMBL indications: Hypertension
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tauroselcholic Acid

- Active moiety: TAUROSELCHOLIC (UNII H6630PU5ZJ)
- Disease: —
- Approved by: EEA national; authorised in 13 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Carbimazole

- Active moiety: CARBIMAZOLE (UNII 8KQ660G60G)
- Disease: Thyroid Diseases
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 82 PubMed papers, 7 registered trials
- ChEMBL indications: Thyroid Diseases, Thyrotoxicosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Dothiepin

- Active moiety: DOSULEPIN (UNII W13O82Z7HL)
- Disease: —
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 3 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Ethamsylate

- Active moiety: ETAMSILATE (UNII 24YL531VOH)
- Disease: —
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Gliquidone

- Active moiety: GLIQUIDONE (UNII C7C2QDD75P)
- Disease: Diabetes Mellitus
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 5 registered trials
- ChEMBL indications: Diabetes Mellitus
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ipidacrine

- Active moiety: IPIDACRINE (UNII CV71VTP0VN)
- Disease: —
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Dementia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Isoconazole

- Active moiety: ISOCONAZOLE (UNII GRI7WFR424)
- Disease: —
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Lormetazepam

- Active moiety: LORMETAZEPAM (UNII GU56C842ZA)
- Disease: Anxiety; Dementia; Depressive Disorder; Sleep Wake Disorders; Schizophrenia
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 6 registered trials
- ChEMBL indications: Anxiety, Dementia, Depressive Disorder, Sleep Wake Disorders, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Troxerutin

- Active moiety: TROXERUTIN (UNII 7Y4N11PXO8)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 12 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 6 registered trials
- ChEMBL indications: Cardiovascular Diseases, Angina, Stable, Inflammation
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Celiprolol

- Active moiety: CELIPROLOL (UNII DRB57K47QC)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 4 registered trials
- ChEMBL indications: Cardiovascular Diseases, Ehlers-Danlos Syndrome
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Choline Salicylate

- Active moiety: — (UNII KD510K1IQW)
- Disease: Pain; Fever
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 376 registered trials
- ChEMBL indications: Pain, Fever
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'OTC MONOGRAPH DRUG']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Clodronic Acid

- Active moiety: CLODRONATE (UNII 0813BZ6866)
- Disease: —
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 20 PubMed papers, 17 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Clomethiazole

- Active moiety: CLOMETHIAZOLE (UNII 0C5DBZ19HV)
- Disease: Anxiety; Dementia; Depressive Disorder; Schizophrenia
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 1 registered trials
- ChEMBL indications: Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Hydrotalcite

- Active moiety: HYDROTALCITE (UNII 17432CG1KU)
- Disease: —
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 7 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Lornoxicam

- Active moiety: LORNOXICAM (UNII ER09126G7A)
- Disease: Rheumatic Diseases
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 21 registered trials
- ChEMBL indications: Rheumatic Diseases, Pain, Alzheimer Disease, Migraine Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tenoxicam

- Active moiety: TENOXICAM (UNII Z1R9N0A399)
- Disease: Rheumatic Diseases
- Approved by: EEA national, Health Canada; authorised in 11 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 4 PubMed papers, 41 registered trials
- ChEMBL indications: Rheumatic Diseases, Pain
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Vinpocetine

- Active moiety: VINPOCETINE (UNII 543512OBTC)
- Disease: Attention Deficit Disorder with Hyperactivity
- Approved by: EEA national; authorised in 11 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 9 registered trials
- ChEMBL indications: Attention Deficit Disorder with Hyperactivity, Diabetic Nephropathies, Epilepsy
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Buserelin

- Active moiety: BUSERELIN (UNII PXW8U3YXDV)
- Disease: Neoplasms
- Approved by: EEA national; authorised in 10 EEA countries; status: authorised
- Research activity: 12 PubMed papers, 42 registered trials
- ChEMBL indications: Neoplasms, Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasms, Infertility
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Cilazapril

- Active moiety: CILAZAPRIL (UNII 19KW7PI29F)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 10 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 4 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Drotaverine

- Active moiety: DROTAVERINE (UNII 98QS4N58TW)
- Disease: Digestive System Diseases; Bile Duct Diseases
- Approved by: EEA national; authorised in 10 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 6 registered trials
- ChEMBL indications: Digestive System Diseases, Bile Duct Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Melperone

- Active moiety: MELPERONE (UNII J8WA3K39B7)
- Disease: Psychotic Disorders; Anxiety; Dementia; Depressive Disorder; Schizophrenia
- Approved by: EEA national; authorised in 10 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 4 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Quinagolide

- Active moiety: QUINAGOLIDE (UNII 80Q9QWN15M)
- Disease: —
- Approved by: EEA national; authorised in 10 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 6 registered trials
- ChEMBL indications: Ovarian Hyperstimulation Syndrome
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Raltitrexed

- Active moiety: RALTITREXED (UNII FCB9EGG971)
- Disease: Neoplasms
- Approved by: EEA national; authorised in 10 EEA countries; status: authorised
- Research activity: 8 PubMed papers, 87 registered trials
- ChEMBL indications: Neoplasms, Mesothelioma, Carcinoma, Squamous Cell, Colorectal Neoplasms, Carcinoma, Hepatocellular, Liver Neoplasms
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Acemetacin

- Active moiety: ACEMETACIN (UNII 5V141XK28X)
- Disease: Rheumatic Diseases
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 2 registered trials
- ChEMBL indications: Rheumatic Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Brivudine

- Active moiety: BRIVUDINE (UNII 2M3055079H)
- Disease: —
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 2 PubMed papers, 2 registered trials
- ChEMBL indications: Virus Diseases, Pancreatic Neoplasms, Colorectal Neoplasms
- EU orphan designation: Treatment of pancreatic cancer (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Brotizolam

- Active moiety: BROTIZOLAM (UNII 5XZM1R3DKF)
- Disease: Sleep Initiation and Maintenance Disorders; Anxiety; Dementia; Depressive Disorder; Sleep Wake Disorders; Schizophrenia
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 10 registered trials
- ChEMBL indications: Sleep Initiation and Maintenance Disorders, Anxiety, Dementia, Depressive Disorder, Sleep Wake Disorders, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Etilefrine

- Active moiety: ETILEFRINE (UNII ZB6F8MY53V)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 7 PubMed papers, 2 registered trials
- ChEMBL indications: Cardiovascular Diseases, Ascites
- EU orphan designation: Treatment of low-flow priapism (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Flunarizine

- Active moiety: FLUNARIZINE (UNII R7PLA2DM0J)
- Disease: Vertigo
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Research activity: 53 PubMed papers, 21 registered trials
- ChEMBL indications: Vertigo, Migraine Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Nicergoline

- Active moiety: NICERGOLINE (UNII JCV8365FWN)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 6 registered trials
- ChEMBL indications: Cardiovascular Diseases, Anxiety, Dementia, Depressive Disorder, Schizophrenia, Deglutition Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tacalcitol

- Active moiety: TACALCITOL (UNII C2W72OJ5ZU)
- Disease: Psoriasis
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 2 registered trials
- ChEMBL indications: Psoriasis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Temocillin

- Active moiety: TEMOCILLIN (UNII 03QB156W6I)
- Disease: Urinary Tract Infections; Bacterial Infections; Bacteremia
- Approved by: EEA national; authorised in 9 EEA countries; status: authorised
- Research activity: 5 PubMed papers, 16 registered trials
- ChEMBL indications: Urinary Tract Infections, Bacterial Infections, Bacteremia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Chloroxylenol

- Active moiety: CHLOROXYLENOL (UNII 0F32U78V2Q)
- Disease: Inflammation
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 9 registered trials
- ChEMBL indications: Inflammation
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'OTC MONOGRAPH DRUG', 'OTC MONOGRAPH NOT FINAL', 'UNAPPROVED DRUG OTHER']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Flunitrazepam

- Active moiety: FLUNITRAZEPAM (UNII 620X0222FQ)
- Disease: —
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 19 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Lynestrenol

- Active moiety: LYNESTRENOL (UNII N2Z8ALG4U5)
- Disease: —
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 6 PubMed papers, 4 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Magaldrate

- Active moiety: MAGALDRATE (UNII 6V88E24N5T)
- Disease: —
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 4 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'DRUG FOR FURTHER PROCESSING']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Metildigoxin

- Active moiety: METILDIGOXIN (UNII I7GG1YUC5V)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Naftidrofuryl

- Active moiety: NAFTIDROFURYL (UNII 42H8PQ0NMJ)
- Disease: —
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Thiocolchicoside

- Active moiety: THIOCOLCHICOSIDE (UNII T1X8S697GT)
- Disease: Low Back Pain
- Approved by: EEA national; authorised in 8 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 15 registered trials
- ChEMBL indications: Low Back Pain
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Benzocaine

- Active moiety: BENZOCAINE (UNII U3RSY48JW5)
- Disease: Pruritus; Anesthesia; Hemorrhoids; Pharyngitis; Sunburn; Burns
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 49 PubMed papers, 7250 registered trials
- ChEMBL indications: Pruritus, Anesthesia, Hemorrhoids, Pharyngitis, Sunburn, Burns
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING', 'DRUG FOR FURTHER PROCESSING', 'OTC MONOGRAPH DRUG', 'OTC MONOGRAPH NOT FINAL', 'UNAPPROVED DRUG OTHER']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Citicoline

- Active moiety: CITICOLINE (UNII 536BQ2JVC7)
- Disease: Stroke; Amphetamine-Related Disorders; Attention Deficit Disorder with Hyperactivity; Cerebral Infarction; Brain Ischemia; Brain Injuries
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 6 PubMed papers, 72 registered trials
- ChEMBL indications: Stroke, Amphetamine-Related Disorders, Attention Deficit Disorder with Hyperactivity, Cerebral Infarction, Brain Ischemia, Brain Injuries
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Myrtecaine

- Active moiety: MYRTECAINE (UNII 9902116282)
- Disease: —
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Niflumic Acid

- Active moiety: NIFLUMIC (UNII 4U5MP5IUD8)
- Disease: —
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 9 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pipamperone

- Active moiety: PIPAMPERONE (UNII 5402501F0W)
- Disease: Psychotic Disorders; Anxiety; Dementia; Depressive Disorder, Major; Depressive Disorder; Schizophrenia
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 6 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Major, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Piribedil

- Active moiety: PIRIBEDIL (UNII DO22K1PRDJ)
- Disease: —
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 5 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Piritramide

- Active moiety: PIRITRAMIDE (UNII 4RP92LYZ2F)
- Disease: Pain
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 18 PubMed papers, 25 registered trials
- ChEMBL indications: Pain
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pizotyline

- Active moiety: PIZOTIFEN (UNII 0BY8440V3N)
- Disease: —
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 8 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sulprostone

- Active moiety: SULPROSTONE (UNII 501Q5EQ1GM)
- Disease: —
- Approved by: EEA national; authorised in 7 EEA countries; status: authorised
- Research activity: 8 PubMed papers, 5 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Canrenoate Potassium

- Active moiety: POTASSIUM CANRENOATE (UNII M671F9NLEA)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 20 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cinolazepam

- Active moiety: CINOLAZEPAM (UNII 68P0556B0U)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Diflucortolone

- Active moiety: DIFLUCORTOLONE (UNII K253365DXI)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 3 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Flutrimazole

- Active moiety: FLUTRIMAZOLE (UNII 776S0UP252)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Imidapril

- Active moiety: IMIDAPRIL (UNII BW7H1TJS22)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 5 registered trials
- ChEMBL indications: Cardiovascular Diseases, Essential Hypertension, Polycystic Kidney, Autosomal Dominant
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Levosulpiride

- Active moiety: LEVOSULPIRIDE (UNII JTG7R315LK)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 5 registered trials
- ChEMBL indications: Psychotic Disorders, Psychomotor Agitation, Dyspepsia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: STEREO_NAME: name carries an enantiomer/racemate marker; check the counterpart's US status by hand

### Loprazolam

- Active moiety: LOPRAZOLAM (UNII 759N8462G8)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Mesterolone

- Active moiety: MESTEROLONE (UNII 0SRQ75X9I9)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nifuratel

- Active moiety: NIFURATEL (UNII U60U6P08SP)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nomegestrol

- Active moiety: NOMEGESTROL (UNII 10F89177CO)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 22 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Pridinol

- Active moiety: PRIDINOL (UNII 9E75Q6SUUB)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Tofisopam

- Active moiety: TOFISOPAM (UNII UZC80HAU42)
- Disease: —
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 2 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Triflusal

- Active moiety: TRIFLUSAL (UNII 1Z0YFI05OO)
- Disease: Thrombosis
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 6 registered trials
- ChEMBL indications: Thrombosis, Insulin Resistance
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ubidecarenone

- Active moiety: UBIDECARENONE (UNII EJ27X76M46)
- Disease: Cardiovascular Diseases; Pre-Eclampsia; Fatigue Syndrome, Chronic; Multiple Organ Failure
- Approved by: EEA national; authorised in 6 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 285 registered trials
- ChEMBL indications: Cardiovascular Diseases, Pre-Eclampsia, Fatigue Syndrome, Chronic, Multiple Organ Failure, Carcinoma, Hepatocellular, Death, Sudden, Cardiac
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING', 'UNAPPROVED DRUG OTHER', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Chloropyramine

- Active moiety: CHLOROPYRAMINE (UNII 2K3L8O9SOV)
- Disease: —
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 1 registered trials
- ChEMBL indications: Pruritus, Hypersensitivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ciprofibrate

- Active moiety: CIPROFIBRATE (UNII F8252JGO9S)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 4 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Enoximone

- Active moiety: ENOXIMONE (UNII C7Z4ITI7L7)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 20 PubMed papers, 8 registered trials
- ChEMBL indications: Cardiovascular Diseases, Heart Failure, Coronary Disease
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Medazepam

- Active moiety: MEDAZEPAM (UNII P0J3387W3S)
- Disease: Anxiety
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 2 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Mizolastine

- Active moiety: MIZOLASTINE (UNII 244O1F90NA)
- Disease: Hypersensitivity
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 1 registered trials
- ChEMBL indications: Hypersensitivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nicorandil

- Active moiety: NICORANDIL (UNII 260456HAM0)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 14 PubMed papers, 44 registered trials
- ChEMBL indications: Cardiovascular Diseases, Myocardial Infarction, Dementia, Premature Birth, Coronary Disease, Cognitive Dysfunction
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nifuroxazide

- Active moiety: NIFUROXAZIDE (UNII PM5LI0P38J)
- Disease: Brain Diseases
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 3 registered trials
- ChEMBL indications: Brain Diseases, Inflammatory Bowel Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nitroxoline

- Active moiety: NITROXOLINE (UNII A8M33244M6)
- Disease: Bacterial Infections
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sulbutiamine

- Active moiety: SULBUTIAMINE (UNII 42NCM1BW43)
- Disease: —
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tolfenamic Acid

- Active moiety: TOLFENAMIC (UNII 3G943U18KM)
- Disease: —
- Approved by: EEA national; authorised in 5 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 4 PubMed papers, 2 registered trials
- EU orphan designation: treatment of behavioural variant frontotemporal dementia (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Acipimox

- Active moiety: ACIPIMOX (UNII K9AY9IR2SD)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 25 registered trials
- ChEMBL indications: Cardiovascular Diseases, Diabetes Mellitus, Type 1, Metabolic Syndrome, Heart Failure, Bulimia Nervosa, Diabetes Mellitus, Type 2
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ademetionine

- Active moiety: ADEMETIONINE (UNII 7LP2MPO46S)
- Disease: Non-alcoholic Fatty Liver Disease; Cholestasis, Intrahepatic; Liver Diseases; Hepatitis
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 69 registered trials
- ChEMBL indications: Non-alcoholic Fatty Liver Disease, Cholestasis, Intrahepatic, Liver Diseases, Hepatitis, Liver Cirrhosis, Biliary, Depressive Disorder, Major
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Alizapride

- Active moiety: ALIZAPRIDE (UNII P55703ZRZY)
- Disease: Digestive System Diseases
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 3 registered trials
- ChEMBL indications: Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Antipyrine

- Active moiety: PHENAZONE (UNII T3CHA1B51H)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 47 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Barnidipine

- Active moiety: BARNIDIPINE (UNII 2VBY96ASWJ)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Biclotymol

- Active moiety: BICLOTYMOL (UNII W4K0AE8XW9)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bromperidol

- Active moiety: BROMPERIDOL (UNII LYH6F7I22E)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Carbenoxolone

- Active moiety: CARBENOXOLONE (UNII MM6384NG73)
- Disease: Gastroesophageal Reflux; Peptic Ulcer
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 19 PubMed papers, 0 registered trials
- ChEMBL indications: Gastroesophageal Reflux, Peptic Ulcer
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cinitapride

- Active moiety: CINITAPRIDE (UNII R8I97I2L24)
- Disease: Dyspepsia; Digestive System Diseases
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Dyspepsia, Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clobetasone

- Active moiety: CLOBETASONE (UNII LT69WY1J6D)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 5 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Cloperastine

- Active moiety: CLOPERASTINE (UNII 69M5L7BXEK)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 0 registered trials
- ChEMBL indications: Cough
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clotiazepam

- Active moiety: CLOTIAZEPAM (UNII ZCN055599V)
- Disease: Anxiety
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Diacerein

- Active moiety: DIACEREIN (UNII 4HU6J11EL5)
- Disease: Rheumatic Diseases
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 4 PubMed papers, 39 registered trials
- ChEMBL indications: Rheumatic Diseases, Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Arthritis, Rheumatoid, Gout
- EU orphan designation: Treatment of epidermolysis bullosa (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Dibrompropamidine

- Active moiety: DIBROMPROPAMIDINE (UNII 269M3QL74S)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- ChEMBL indications: Eye Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ethyl Loflazepate

- Active moiety: ETHYL LOFLAZEPATE (UNII VJB5FW9W9J)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Fenoterol

- Active moiety: FENOTEROL (UNII 22M9P70OQ9)
- Disease: Lung Diseases, Obstructive
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 12 PubMed papers, 25 registered trials
- ChEMBL indications: Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Asthma, Heart Failure
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Fluspirilene

- Active moiety: FLUSPIRILENE (UNII C5QA4GLR9M)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 19 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Hexoprenaline

- Active moiety: HEXOPRENALINE (UNII G9L6B3W684)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- ChEMBL indications: Lung Diseases, Obstructive
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Hymecromone

- Active moiety: HYMECROMONE (UNII 3T5NG4Q468)
- Disease: —
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 0 PubMed papers, 6 registered trials
- ChEMBL indications: Cholangitis, Sclerosing, Hypertension, Pulmonary, Respiratory Tract Diseases
- EU orphan designation: Treatment of spinal cord injury (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Idebenone

- Active moiety: IDEBENONE (UNII HB6PN45W4J)
- Disease: Optic Atrophy, Hereditary, Leber
- Indication: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
- Approved by: EMA, EEA national; authorised in 4 EEA countries; status: authorised
- Flags: orphan, EU orphan designation, US filed & refused, multi-regulator
- ATC: N06BX13
- Research activity: 36 PubMed papers, 35 registered trials
- ChEMBL indications: Attention Deficit Disorder with Hyperactivity, Optic Atrophy, Hereditary, Leber, Muscular Dystrophy, Duchenne, Friedreich Ataxia, MELAS Syndrome, Multiple Sclerosis, Chronic Progressive
- EU orphan designation: Treatment of Leber's hereditary optic neuropathy (Expired)
- US prior filing: COMPLETE RESPONSE — NDA (Chiesi, LHON) · 02/27/2026
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Indobufen

- Active moiety: INDOBUFEN (UNII 6T9949G4LZ)
- Disease: Thrombosis; Atrial Fibrillation
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 14 registered trials
- ChEMBL indications: Thrombosis, Atrial Fibrillation
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Oxitriptan

- Active moiety: OXITRIPTAN (UNII C1LJO185Q9)
- Disease: Depressive Disorder
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 30 registered trials
- ChEMBL indications: Depressive Disorder, Sleep Wake Disorders, Spinal Cord Injuries, Depressive Disorder, Major, Obesity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Pefloxacin

- Active moiety: PEFLOXACIN (UNII 2H52Z9F2Q5)
- Disease: Bacterial Infections
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 12 PubMed papers, 2 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Periciazine

- Active moiety: PERICIAZINE (UNII 3405M6FD73)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Psychotic Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Promestriene

- Active moiety: PROMESTRIENE (UNII GXM4PER6WZ)
- Disease: Hypospadias
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 10 registered trials
- ChEMBL indications: Hypospadias
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Prothipendyl

- Active moiety: PROTHIPENDYL (UNII 5O6VWA87VA)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tolnaftate

- Active moiety: TOLNAFTATE (UNII 06KB629TKV)
- Disease: Infections; Tinea; Tinea Pedis; Pruritus
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 34 registered trials
- ChEMBL indications: Infections, Tinea, Tinea Pedis, Pruritus, Eczema
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'DRUG FOR FURTHER PROCESSING', 'OTC MONOGRAPH DRUG', 'OTC MONOGRAPH FINAL', 'UNAPPROVED DRUG OTHER', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Vindesine

- Active moiety: VINDESINE (UNII RSA8KO39WH)
- Disease: Neoplasms
- Approved by: EEA national; authorised in 4 EEA countries; status: authorised
- Research activity: 26 PubMed papers, 85 registered trials
- ChEMBL indications: Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphoma, Neuroblastoma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ambazone

- Active moiety: AMBAZONE (UNII BYK4592A3Q)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bamipine

- Active moiety: BAMIPINE (UNII Y6BHZ28O92)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Pruritus, Hypersensitivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Benzbromarone

- Active moiety: BENZBROMARONE (UNII 4POG0RL69O)
- Disease: Gout
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 13 registered trials
- ChEMBL indications: Gout, Hyperuricemia, Familial Primary Pulmonary Hypertension
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bornaprine

- Active moiety: BORNAPRINE (UNII 9M363FGA7J)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Parkinson Disease
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clebopride

- Active moiety: CLEBOPRIDE (UNII I0A84520Y9)
- Disease: Digestive System Diseases
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clothiapine

- Active moiety: CLOTIAPINE (UNII Z05HCY0X1T)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cystine

- Active moiety: L CYSTINE (UNII 48TCX9A1VT)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 31 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Delamanid

- Active moiety: DELAMANID (UNII 8OOT6M1PC7)
- Disease: Tuberculosis
- Indication: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: rare disease, multi-regulator
- ATC: J04AK06
- Research activity: 40 PubMed papers, 44 registered trials
- ChEMBL indications: Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Orphadata: Tuberculosis; rarity rare; onset mixed
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [PASS] rare under 200k: Orphanet 1-5 / 10 000 (Europe) ≈ 100,499 in the US, under 200,000 (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: Orphanet age of onset: All ages — spans pediatric and adult (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ergonovine

- Active moiety: ERGOMETRINE (UNII WH41D8433D)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 27 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Ethacridine

- Active moiety: ETHACRIDINE (UNII WIX85M1A6R)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Etifoxine

- Active moiety: ETIFOXINE (UNII X24X82MX4X)
- Disease: Anxiety
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Filgotinib

- Active moiety: FILGOTINIB (UNII 3XVL385Q0M)
- Disease: Arthritis, Rheumatoid
- Indication: Rheumatoid arthritis Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Ulcerative colitis Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: L04AF04
- Research activity: 11 PubMed papers, 66 registered trials
- ChEMBL indications: Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Spondylitis, Ankylosing, Spondylarthropathies
- US prior filing: COMPLETE RESPONSE — NDA (Gilead, rheumatoid arthritis) · 08/18/2020
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Fluprednidene

- Active moiety: FLUPREDNIDENE (UNII FA517NS3N7)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Gefapixant

- Active moiety: GEFAPIXANT (UNII 6K6L7E3F1L)
- Disease: Cough
- Indication: Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: R05DB29
- Research activity: 0 PubMed papers, 27 registered trials
- ChEMBL indications: Cough, Idiopathic Pulmonary Fibrosis, Osteoarthritis, Knee, Cystitis, Interstitial, Asthma, Sleep Apnea, Obstructive
- US prior filing: COMPLETE RESPONSE — NDA (Merck, chronic cough) · 12/20/2023
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Linzagolix

- Active moiety: LINZAGOLIX (UNII 7CDW97HUEX)
- Disease: Leiomyoma
- Indication: Yselty is indicated in adult women of reproductive age for: -           treatment of moderate to severe symptoms of uterine fibroids,-           symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1).
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: H01CC04
- Research activity: 0 PubMed papers, 18 registered trials
- ChEMBL indications: Endometriosis, Leiomyoma, Liver Diseases, Kidney Diseases
- US prior filing: NDA WITHDRAWN BEFORE ACTION — NDA (ObsEva/Kissei, uterine fibroids) · 08/22/2022
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['EXPORT ONLY']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Mifamurtide

- Active moiety: MIFAMURTIDE (UNII 1LM890Q4FY)
- Disease: Osteosarcoma
- Indication: Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: rare disease, pediatric onset, EU orphan designation, US filed & refused, multi-regulator
- ATC: L03AX15
- Research activity: 16 PubMed papers, 8 registered trials
- ChEMBL indications: Osteosarcoma, Neoplasms
- EU orphan designation: Treatment of echinococcosis (Positive)
- Orphadata: Osteosarcoma; rarity rare; onset pediatric
- US prior filing: NOT APPROVABLE — NDA (IDM Pharma, osteosarcoma) · 08/27/2007
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [PASS] rare under 200k: Orphanet 1-9 / 100 000 (Europe) ≈ 16,750 in the US, under 200,000 (s.529(a)(3)(B))
  - [PASS] primarily pediatric: Orphanet age of onset: Childhood — within birth-18 (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nadifloxacin

- Active moiety: NADIFLOXACIN (UNII 6CL9Y5YZEQ)
- Disease: Acne Vulgaris
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 3 registered trials
- ChEMBL indications: Acne Vulgaris
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Naftazone

- Active moiety: NAFTAZONE (UNII 15B0523P5L)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Opipramol

- Active moiety: OPIPRAMOL (UNII D23ZXO613C)
- Disease: Anxiety; Dementia; Depressive Disorder; Schizophrenia
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- ChEMBL indications: Anxiety, Dementia, Depressive Disorder, Schizophrenia, Substance-Related Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Ornidazole

- Active moiety: ORNIDAZOLE (UNII 62XCK0G93T)
- Disease: Bacterial Infections; Amebiasis
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 6 PubMed papers, 9 registered trials
- ChEMBL indications: Bacterial Infections, Amebiasis, Rectal Neoplasms, Colonic Neoplasms
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Oxaceprol

- Active moiety: OXACEPROL (UNII Q0XV76B96L)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Rheumatic Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Padeliporfin

- Active moiety: PADELIPORFIN (UNII EEO29FZT86)
- Disease: Neoplasms
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 12 registered trials
- ChEMBL indications: Neoplasms, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Prostatic Neoplasms, Castration-Resistant, Urinary Bladder Neoplasms, Kidney Neoplasms
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pentetreotide

- Active moiety: PENTETREOTIDE (UNII G083B71P98)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 7 PubMed papers, 15 registered trials
- ChEMBL indications: Neuroendocrine Tumors
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Perflubutane

- Active moiety: PERFLUBUTANE (UNII SE4TWR0K2C)
- Disease: Ultrasonography
- Indication: ultrasound imaging agent indicated for the detection of coronary artery disease (CAD)
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: multi-regulator
- ATC: V08D
- Research activity: 2 PubMed papers, 20 registered trials
- ChEMBL indications: Hypertension, Portal, Carcinoma, Pancreatic Ductal
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pramiracetam

- Active moiety: PRAMIRACETAM (UNII 4449F8I3LE)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Attention Deficit Disorder with Hyperactivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Prulifloxacin

- Active moiety: PRULIFLOXACIN (UNII J42298IESW)
- Disease: Bronchitis, Chronic; Urinary Tract Infections; Gastroenteritis; Bacterial Infections
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 8 registered trials
- ChEMBL indications: Bronchitis, Chronic, Urinary Tract Infections, Gastroenteritis, Bacterial Infections, Prostatitis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Roxadustat

- Active moiety: ROXADUSTAT (UNII X3O30D9YMX)
- Disease: Anemia;Kidney Failure, Chronic
- Indication: Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: B03XA05
- Research activity: 5 PubMed papers, 66 registered trials
- ChEMBL indications: Anemia, Kidney Failure, Chronic, Myelodysplastic Syndromes, ST Elevation Myocardial Infarction, Kidney Diseases
- US prior filing: COMPLETE RESPONSE — NDA (FibroGen/AstraZeneca, CKD anaemia) · 08/11/2021
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'EXPORT ONLY']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.
- Note: US_ORPHAN_DESIGNATION_HELD: Kyntra Bio (fka FibroGen) granted FDA orphan designation for myelodysplastic syndromes 2025-12 (8-K 2026-01-07); Phase 3 in lower-risk MDS planned Q4 2026; CKD-anaemia NDA CRL 2021-08-11 never resubmitted

### Terizidone

- Active moiety: TERIZIDONE (UNII 1199LEX5N8)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 4 registered trials
- ChEMBL indications: Tuberculosis, Multidrug-Resistant, Tuberculosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tiaprofenic Acid

- Active moiety: TIAPROFENIC (UNII 1LS1T6R34C)
- Disease: —
- Approved by: EEA national; authorised in 3 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tolebrutinib

- Active moiety: TOLEBRUTINIB (UNII 8CZ82ZYY9X)
- Disease: Multiple Sclerosis, Chronic Progressive
- Indication: Cenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: L04AA62
- Research activity: 0 PubMed papers, 12 registered trials
- ChEMBL indications: Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Kidney Diseases
- US prior filing: COMPLETE RESPONSE — NDA 219624 · 12/23/2025
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Vernakalant

- Active moiety: VERNAKALANT (UNII 9G468C8B13)
- Disease: Atrial Fibrillation
- Indication: Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults:  for non-surgery patients: atrial fibrillation </= 7 days duration; for post-cardiac surgery patients: atrial fibrillation </= 3 days duration.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: US filed & refused, multi-regulator
- ATC: C01BG11
- Research activity: 1 PubMed papers, 17 registered trials
- ChEMBL indications: Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- US prior filing: COMPLETE RESPONSE — NDA (Correvio, atrial fibrillation) · 12/24/2019
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Vinflunine

- Active moiety: VINFLUNINE (UNII 5BF646324K)
- Disease: Carcinoma, Transitional Cell;Urologic Neoplasms
- Indication: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ? 2.
- Approved by: EMA, EEA national; authorised in 3 EEA countries; status: authorised
- Flags: multi-regulator
- ATC: L01CA05
- Research activity: 0 PubMed papers, 35 registered trials
- ChEMBL indications: Neoplasms, Urogenital Neoplasms, Urinary Bladder Neoplasms, Head and Neck Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Amylmetacresol

- Active moiety: AMYLMETACRESOL (UNII 05W904P57F)
- Disease: —
- Approved by: EEA national, Health Canada; authorised in 2 EEA countries; status: authorised
- Flags: multi-regulator
- Research activity: 0 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Azidamfenicol

- Active moiety: AZIDAMFENICOL (UNII 40257685LM)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Eye Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bencyclane

- Active moiety: BENCYCLANE (UNII 6I97Z6S135)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Benperidol

- Active moiety: BENPERIDOL (UNII 97O6X78C53)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 4 registered trials
- ChEMBL indications: Psychotic Disorders, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Chlormadinone

- Active moiety: CHLORMADINONE (UNII SDS4N642GG)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 7 PubMed papers, 4 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Chlorphenoxamine

- Active moiety: CHLORPHENOXAMINE (UNII 3UVD77BP8R)
- Disease: Pruritus; Hypersensitivity
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Pruritus, Hypersensitivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Chlorquinaldol

- Active moiety: CHLORQUINALDOL (UNII D6VHC87LLS)
- Disease: Amebiasis
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- ChEMBL indications: Amebiasis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Choline Alfoscerate

- Active moiety: CHOLINE ALFOSCERATE (UNII 60M22SGW66)
- Disease: Diabetes Mellitus, Type 2
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 28 registered trials
- ChEMBL indications: Diabetes Mellitus, Type 2, Cognitive Dysfunction
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Clopamide

- Active moiety: CLOPAMIDE (UNII 17S83WON0I)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clorophene

- Active moiety: CLOROFENE (UNII 7560BB0BO3)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cobamamide

- Active moiety: COBAMAMIDE (UNII F0R1QK73KB)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- ChEMBL indications: Anemia, Dermatitis, Atopic
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED DRUG OTHER']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Cyamemazine

- Active moiety: CYAMEMAZINE (UNII A2JGV5CNU4)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Psychotic Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Dehydrocholic Acid

- Active moiety: DEHYDROCHOLIC (UNII NH5000009I)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 5 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Dihydralazine

- Active moiety: DIHYDRALAZINE (UNII PCU411F5L6)
- Disease: Hypertension; Aortic Valve Stenosis
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 2 registered trials
- ChEMBL indications: Hypertension, Aortic Valve Stenosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Etofylline

- Active moiety: ETOFYLLINE (UNII L164909TBI)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Felbinac

- Active moiety: FELBINAC (UNII 94WNJ5U8L7)
- Disease: Myalgia; Arthralgia
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 6 registered trials
- ChEMBL indications: Myalgia, Arthralgia, Pain, Thromboembolism, Neoplasms, Acute Kidney Injury
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Fenipentol

- Active moiety: FENIPENTOL (UNII X3FZE77O60)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Flubendazole

- Active moiety: FLUBENDAZOLE (UNII R8M46911LR)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 1 registered trials
- ChEMBL indications: Helminthiasis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Fluindione

- Active moiety: FLUINDIONE (UNII EQ35YMS20Q)
- Disease: Thrombosis
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 14 registered trials
- ChEMBL indications: Thrombosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Gaxilose

- Active moiety: GAXILOSE (UNII A571S2B3JE)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Indoramin

- Active moiety: INDORAMIN (UNII 0Z802HMY7H)
- Disease: Hypertension
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Hypertension
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Iprazochrome

- Active moiety: IPRAZOCHROME (UNII 903A9K181P)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Migraine Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Lofepramine

- Active moiety: LOFEPRAMINE (UNII OCA4JT7PAW)
- Disease: Depressive Disorder
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Depressive Disorder
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Lutetium Lu-177 Zadavotide Guraxetan

- Active moiety: LUTETIUM 177LU ZADAVOTIDE GURAXETAN (UNII G5B860B0G1)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Metergoline

- Active moiety: METERGOLINE (UNII 1501393LY5)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Mexazolam

- Active moiety: MEXAZOLAM (UNII S5969B6237)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Morniflumate

- Active moiety: MORNIFLUMATE (UNII R133MWH7X1)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 0 registered trials
- ChEMBL indications: Rheumatic Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Penfluridol

- Active moiety: PENFLURIDOL (UNII 25TLU22Q8H)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 1 registered trials
- ChEMBL indications: Psychotic Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pheneticillin

- Active moiety: PHENETICILLIN (UNII EFA30X554H)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pholcodine

- Active moiety: PHOLCODINE (UNII LPP64AWZ7L)
- Disease: Cough
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 2 registered trials
- ChEMBL indications: Cough
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Piketoprofen

- Active moiety: PIKETOPROFEN (UNII 362QBC4NL0)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Arthralgia, Myalgia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pirenoxine

- Active moiety: PIRENOXINE (UNII 27L0EP6IZK)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Prenoxdiazine

- Active moiety: PRENOXDIAZIN (UNII S491HH391H)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Protionamide

- Active moiety: PROTIONAMIDE (UNII 76YOO33643)
- Disease: Tuberculosis
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Flags: rare disease
- Research activity: 2 PubMed papers, 15 registered trials
- ChEMBL indications: Tuberculosis, Tuberculosis, Pulmonary
- Orphadata: Tuberculosis; rarity rare; onset mixed
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [PASS] rare under 200k: Orphanet 1-5 / 10 000 (Europe) ≈ 100,499 in the US, under 200,000 (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: Orphanet age of onset: All ages — spans pediatric and adult (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pyritinol

- Active moiety: PYRITINOL (UNII AK5Q5FZH2R)
- Disease: Attention Deficit Disorder with Hyperactivity
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- ChEMBL indications: Attention Deficit Disorder with Hyperactivity, Anxiety, Dementia, Depressive Disorder, Schizophrenia
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Quifenadine

- Active moiety: QUIFENADINE (UNII W9A18RJ49B)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Hypersensitivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sodium Picofosfate

- Active moiety: SODIUM PICOFOSFATE (UNII 9164VT6ANB)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Spaglumic Acid

- Active moiety: SPAGLUMIC (UNII X81L78B3RB)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tribenoside

- Active moiety: TRIBENOSIDE (UNII Z7N0Y673NU)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 2 registered trials
- ChEMBL indications: Cardiovascular Diseases, Hemorrhoids
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Trimecaine

- Active moiety: TRIMECAINE (UNII IN1233R0JO)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Valpromide

- Active moiety: VALPROMIDE (UNII RUA6CWU76G)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 9 PubMed papers, 1 registered trials
- ChEMBL indications: Epilepsy
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Vinburnine

- Active moiety: VINBURNINE (UNII G54D0HMY25)
- Disease: —
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Xipamide

- Active moiety: XIPAMIDE (UNII 4S9EY0NUEC)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Zotepine

- Active moiety: ZOTEPINE (UNII U29O83JAZW)
- Disease: Psychotic Disorders
- Approved by: EEA national; authorised in 2 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- ChEMBL indications: Psychotic Disorders
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Alfatradiol

- Active moiety: ALFATRADIOL (UNII 3VQ38D63M7)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Almagate

- Active moiety: ALMAGATE (UNII 568Z59H7ZJ)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Almasilate

- Active moiety: ALMASILATE (UNII OZQ8O62H53)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Amitriptylinoxide

- Active moiety: AMITRIPTYLINOXIDE (UNII TYR2U59WMA)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Androstanolone

- Active moiety: ANDROSTANOLONE (UNII 08J2K08A3Y)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Aniracetam

- Active moiety: ANIRACETAM (UNII 5L16LKN964)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Attention Deficit Disorder with Hyperactivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Anthralin

- Active moiety: DITHRANOL (UNII U8CJK0JH5M)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 6 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Arlipoic Acid

- Active moiety: LIPOIC (UNII VLL71EBS9Z)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 42 PubMed papers, 241 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Benproperine

- Active moiety: BENPROPERINE (UNII 3AA6IZ48YK)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cough
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bromopride

- Active moiety: BROMOPRIDE (UNII 75473V2YZK)
- Disease: Dyspepsia; Digestive System Diseases
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Dyspepsia, Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Bronopol

- Active moiety: BRONOPOL (UNII 6PU1E16C9W)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 4 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Carbaldrate

- Active moiety: CARBALDRATE (UNII 6931E8LH07)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Carbazochrome

- Active moiety: CARBAZOCHROME (UNII 81F061RQS4)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Hemorrhage
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Caroverine

- Active moiety: CAROVERINE (UNII XJ73B0K6KB)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- ChEMBL indications: Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cefatrizine

- Active moiety: CEFATRIZINE (UNII 8P4W949T8K)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 6 PubMed papers, 2 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Chlorobutanol

- Active moiety: CHLOROBUTANOL (UNII HM4YQM8WRC)
- Disease: Nausea
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 7 registered trials
- ChEMBL indications: Nausea
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Chlorocresol

- Active moiety: CHLOROCRESOL (UNII 36W53O7109)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cicletanine

- Active moiety: CICLETANINE (UNII CHG7QC509W)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Hypertension, Pulmonary, Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Cifenline

- Active moiety: CIBENZOLINE (UNII Z7489237QT)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 3 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clofoctol

- Active moiety: CLOFOCTOL (UNII 704083NI0R)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Clonixin

- Active moiety: CLONIXIN (UNII V7DXN0M42R)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cloprednol

- Active moiety: CLOPREDNOL (UNII SYP56O3GJG)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cloxazolam

- Active moiety: CLOXAZOLAM (UNII GYL649Z0HY)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Cortivazol

- Active moiety: CORTIVAZOL (UNII YM183K0H63)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 4 registered trials
- ChEMBL indications: Pain
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Delorazepam

- Active moiety: DELORAZEPAM (UNII O91W32476G)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Demoxytocin

- Active moiety: DEMOXYTOCIN (UNII 2N9HM3X95F)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Denotivir

- Active moiety: DENOTIVIR (UNII W656S9I00W)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Dimethisoquin

- Active moiety: QUINISOCAINE (UNII 772EN3BH6I)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Doxofylline

- Active moiety: DOXOFYLLINE (UNII MPM23GMO7Z)
- Disease: Lung Diseases, Obstructive; Asthma
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 7 registered trials
- ChEMBL indications: Lung Diseases, Obstructive, Asthma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Eberconazole

- Active moiety: EBERCONAZOLE (UNII V7O1U41C9B)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Etizolam

- Active moiety: ETIZOLAM (UNII A76XI0HL37)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Flufenamic Acid

- Active moiety: FLUFENAMIC (UNII 60GCX7Y6BH)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Fosfructose

- Active moiety: FRUCTOSE 1 6 (UNII M7522JYX1H)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 35 PubMed papers, 39 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Fotemustine

- Active moiety: FOTEMUSTINE (UNII GQ7JL9P5I2)
- Disease: Neoplasms; Melanoma; Uveal Melanoma
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 14 registered trials
- ChEMBL indications: Neoplasms, Melanoma, Uveal Melanoma, Glioblastoma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Framycetin

- Active moiety: FRAMYCETIN (UNII 4BOC774388)
- Disease: Nasal Obstruction; Eye Infections
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Nasal Obstruction, Eye Infections, Osteomyelitis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Fumagillin

- Active moiety: FUMAGILLIN (UNII 7OW73204U1)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 4 PubMed papers, 0 registered trials
- ChEMBL indications: Amebiasis
- EU orphan designation: Treatment of diarrhoea associated with intestinal microsporidial infection (Withdrawn)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Gabexate

- Active moiety: GABEXATE (UNII 4V7M9137X9)
- Disease: Liver Diseases
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 9 registered trials
- ChEMBL indications: Liver Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Glutaral

- Active moiety: GLUTARAL (UNII T3C89M417N)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 41 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Heptaminol

- Active moiety: HEPTAMINOL (UNII 3DQS188SY5)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ibopamine

- Active moiety: IBOPAMINE (UNII 8ZCA2I2L11)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Iproniazid

- Active moiety: IPRONIAZID (UNII D892HFI3XA)
- Disease: Depressive Disorder
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Depressive Disorder
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Isothipendyl

- Active moiety: ISOTHIPENDYL (UNII WVZ7K9P0JY)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Pruritus, Hypersensitivity
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Josamycin

- Active moiety: JOSAMYCIN (UNII HV13HFS217)
- Disease: Premature Birth; Bacterial Infections
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 26 PubMed papers, 1 registered trials
- ChEMBL indications: Premature Birth, Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Lidofenin

- Active moiety: LIDOFENIN (UNII EK22QV7701)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Medrogestone

- Active moiety: MEDROGESTONE (UNII 077DN93G5B)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Melarsoprol

- Active moiety: MELARSOPROL (UNII ZF3786Q2E8)
- Disease: Trypanosomiasis; Leishmaniasis
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 3 PubMed papers, 1 registered trials
- ChEMBL indications: Trypanosomiasis, Leishmaniasis
- EU orphan designation: Treatment of African trypanosomiasis (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Mephenoxalone

- Active moiety: MEPHENOXALONE (UNII CZ87T54W8W)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 18 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Merbromin

- Active moiety: MERBROMIN (UNII M0T18YH28D)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Methylcobalamin

- Active moiety: METHYLCOBALAMIN (UNII BR1SN1JS2W)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 17 PubMed papers, 627 registered trials
- ChEMBL indications: Autistic Disorder, Multiple Sclerosis
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT', 'BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING', 'DRUG FOR FURTHER PROCESSING', 'UNAPPROVED DRUG OTHER', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Metopimazine

- Active moiety: METOPIMAZINE (UNII 238S75V9AV)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 2 registered trials
- ChEMBL indications: Nausea
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Moxisylyte

- Active moiety: MOXISYLYTE (UNII PW8QYA7KI0)
- Disease: Cardiovascular Diseases; Erectile Dysfunction
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases, Erectile Dysfunction
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Neridronic Acid

- Active moiety: NERIDRONATE (UNII 8U27U3RIN4)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 13 PubMed papers, 7 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Nikethamide

- Active moiety: NIKETHAMIDE (UNII 368IVD6M32)
- Disease: Respiratory Tract Diseases
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Respiratory Tract Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nimorazole

- Active moiety: NIMORAZOLE (UNII 469ULX0H4G)
- Disease: Amebiasis
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Flags: EU orphan designation
- Research activity: 0 PubMed papers, 10 registered trials
- ChEMBL indications: Amebiasis, Carcinoma, Squamous Cell
- EU orphan designation: Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy (Withdrawn)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Nonivamide

- Active moiety: NONIVAMIDE (UNII S846B891OR)
- Disease: Low Back Pain
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- ChEMBL indications: Low Back Pain
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['OTC MONOGRAPH DRUG', 'UNAPPROVED DRUG OTHER']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Nordazepam

- Active moiety: NORDAZEPAM (UNII 67220MCM01)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Norethandrolone

- Active moiety: NORETHANDROLONE (UNII P7W01638W6)
- Disease: Leukemia, Myeloid, Acute
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 1 registered trials
- ChEMBL indications: Leukemia, Myeloid, Acute
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Oxatomide

- Active moiety: OXATOMIDE (UNII J31IL9Z2EE)
- Disease: Hypersensitivity
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 10 PubMed papers, 1 registered trials
- ChEMBL indications: Hypersensitivity, Muscular Dystrophy, Duchenne
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Phenibut

- Active moiety: 4 AMINO 3 PHENYLBUTYRIC (UNII T2M58D6LA8)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 2 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Phenolphthalein

- Active moiety: PHENOLPHTHALEIN (UNII 6QK969R2IF)
- Disease: Constipation
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 4 PubMed papers, 3 registered trials
- ChEMBL indications: Constipation
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Phenothrin

- Active moiety: PHENOTHRIN (UNII 707484X33X)
- Disease: Ectoparasitic Infestations
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 0 registered trials
- ChEMBL indications: Ectoparasitic Infestations
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Picloxydine

- Active moiety: PICLOXYDINE (UNII 4YC2PY3AEU)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Eye Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pidotimod

- Active moiety: PIDOTIMOD (UNII 785363R681)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 18 PubMed papers, 1 registered trials
- ChEMBL indications: Neoplasms
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Pinazepam

- Active moiety: PINAZEPAM (UNII 5286RBZ882)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 1 registered trials
- ChEMBL indications: Anxiety
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pipemidic Acid

- Active moiety: PIPEMIDIC (UNII LT12J5HVR8)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pipotiazine

- Active moiety: PIPOTIAZINE (UNII L903J9JPYV)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pirenzepine

- Active moiety: PIRENZEPINE (UNII 3G0285N20N)
- Disease: Peptic Ulcer; Gastroesophageal Reflux
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 7 PubMed papers, 4 registered trials
- ChEMBL indications: Peptic Ulcer, Gastroesophageal Reflux, Peripheral Nervous System Diseases, Diabetic Neuropathies, Stomach Ulcer
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Piretanide

- Active moiety: PIRETANIDE (UNII DQ6KK6GV93)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pirlindole

- Active moiety: PIRLINDOLE (UNII V39YPH45FZ)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Piroxicam Cinnamate

- Active moiety: PIROXICAM CINNAMATE (UNII 7E8Q32N75N)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pranoprofen

- Active moiety: PRANOPROFEN (UNII 2R7O1ET613)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 8 registered trials
- ChEMBL indications: Eye Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Proflavine

- Active moiety: PROFLAVINE (UNII CY3RNB3K4T)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 22 registered trials
- ChEMBL indications: Carcinoma, Squamous Cell, Barrett Esophagus, Uterine Neoplasms, Genital Neoplasms, Female, Mouth Neoplasms
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Reproterol

- Active moiety: REPROTEROL (UNII 11941YC6RN)
- Disease: Lung Diseases, Obstructive
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 1 registered trials
- ChEMBL indications: Lung Diseases, Obstructive, Asthma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Rociverine

- Active moiety: ROCIVERINE (UNII VI08KS44V0)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Rufloxacin

- Active moiety: RUFLOXACIN (UNII Y521XM2900)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Rutin

- Active moiety: RUTOSIDE (UNII 5G06TVY3R7)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 3 PubMed papers, 55 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['UNAPPROVED DRUG OTHER', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Sodium Aurotiosulfate

- Active moiety: SODIUM AUROTIOSULFATE (UNII CKS1YQ9W1J)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 3 registered trials
- ChEMBL indications: Rheumatic Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sulisobenzone

- Active moiety: SULISOBENZONE (UNII 1W6L629B4K)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Temgicoluril

- Active moiety: TEMGICOLURIL (UNII 55FE6NPG89)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Thiram

- Active moiety: THIRAM (UNII 0D771IS0FH)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Ectoparasitic Infestations
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Trepibutone

- Active moiety: TREPIBUTONE (UNII H1187LU49Q)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Digestive System Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Trimeperidine

- Active moiety: TRIMEPERIDINE (UNII 1M2IB31DTS)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 3 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Trofosfamide

- Active moiety: TROFOSFAMIDE (UNII H64JRU6GJ0)
- Disease: Sarcoma; Neoplasms
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 11 PubMed papers, 4 registered trials
- ChEMBL indications: Sarcoma, Neoplasms, Medulloblastoma, Melanoma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tromantadine

- Active moiety: TROMANTADINE (UNII H191JFG8WA)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Virus Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Tropatepine

- Active moiety: TROPATEPINE (UNII C27HY5RFU5)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- ChEMBL indications: Parkinson Disease
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Vincamine

- Active moiety: VINCAMINE (UNII 996XVD0JHT)
- Disease: Cardiovascular Diseases
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 2 PubMed papers, 0 registered trials
- ChEMBL indications: Cardiovascular Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Xibornol

- Active moiety: XIBORNOL (UNII RQ12GMY0FZ)
- Disease: —
- Approved by: EEA national; authorised in 1 EEA countries; status: authorised
- Research activity: 1 PubMed papers, 0 registered trials
- ChEMBL indications: Bacterial Infections
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Ataluren

- Active moiety: ATALUREN (UNII K16AME9I3V)
- Disease: Duchenne muscular dystrophy
- Indication: Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. Efficacy has not been demonstrated in non-ambulatory patients. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: rare disease, pediatric onset, EU orphan designation, licence pulled
- ATC: M09AX03
- Research activity: 34 PubMed papers, 34 registered trials
- ChEMBL indications: Muscular Dystrophy, Duchenne, Cystic Fibrosis, Epilepsy, Hemophilia A, Hemophilia B, Aniridia
- EU orphan designation: Treatment of Becker muscular dystrophy (Withdrawn)
- Orphadata: Duchenne muscular dystrophy; rarity rare; onset pediatric
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [PASS] rare under 200k: Orphanet 1-9 / 100 000 (Worldwide) ≈ 16,750 in the US, under 200,000 (s.529(a)(3)(B))
  - [PASS] primarily pediatric: Orphanet age of onset: Childhood — within birth-18 (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Aumolertinib

- Active moiety: AUMOLERTINIB (UNII T4RS462G19)
- Disease: Carcinoma, Non-Small-Cell Lung
- Indication: Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: licence pulled
- ATC: L01EB
- Research activity: 0 PubMed papers, 80 registered trials
- ChEMBL indications: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Liver Diseases
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Lasofoxifene

- Active moiety: LASOFOXIFENE (UNII 337G83N988)
- Disease: Osteoporosis, Postmenopausal
- Indication: Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: licence pulled
- ATC: G03
- Research activity: 0 PubMed papers, 9 registered trials
- ChEMBL indications: Osteoporosis, Breast Neoplasms, Hemangiosarcoma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Leriglitazone

- Active moiety: LERIGLITAZONE (UNII K824X25AYA)
- Disease: Adrenoleukodystrophy
- Indication: Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non Gadolinium (Gd) enhancing lesions (i.e. Gd negative) in brain Magnetic Resonance Imaging (MRI), with a Neurological Functional Score (NFS) of 0 or 1.
- Approved by: EMA; authorised in 0 EEA countries; status: authorised
- Flags: orphan, EU orphan designation
- ATC: A16AX23
- Research activity: 2 PubMed papers, 2 registered trials
- ChEMBL indications: Adrenoleukodystrophy, Friedreich Ataxia
- EU orphan designation: Treatment of Friedreich’s ataxia (Positive)
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_RPD_DESIGNATION_HELD: Minoryx holds FDA Rare Pediatric Disease + Fast Track + orphan designations for X-ALD (sponsor-stated); CALYX pivotal fully enrolled 2026-09, FDA-agreed NDA-enabling, topline early 2028 — a US NDA before the 2029-09-30 sunset is plausible but the originator's to file

### Methylparaben

- Active moiety: E 218 (UNII A2I8C7HI9T)
- Disease: —
- Approved by: Swissmedic; authorised in 0 EEA countries; status: authorised
- Research activity: 0 PubMed papers, 0 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))
- Note: US_NON_APPLICATION_MARKETING: sold in the US under ['BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING', 'OTC MONOGRAPH FINAL', 'UNAPPROVED HOMEOPATHIC']. Does NOT disqualify (s.529 bars a prior approval in a 505 application, which these are not) but there is no exclusivity runway and supply already exists — and rows like this are often excipients or antiseptics rather than drugs.

### Perflenapent

- Active moiety: DODECAFLUOROPENTANE (UNII 483AU1Y5CZ)
- Disease: Echocardiography
- Indication: EchoGen is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular border delineation with resulting improvement in wall motion visualisation. EchoGen should only be used in patients where the study without contrast enhancement is inconclusive.
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: licence pulled
- ATC: V08DA
- Research activity: 0 PubMed papers, 6 registered trials
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Pixantrone

- Active moiety: PIXANTRONE (UNII F5SXN2KNMR)
- Disease: Non-Hodgkin lymphoma
- Indication: Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: rare disease, licence pulled
- ATC: L01DB11
- Research activity: 3 PubMed papers, 18 registered trials
- ChEMBL indications: Neoplasms, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell
- Orphadata: Non-Hodgkin lymphoma; rarity rare; onset mixed
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [PASS] rare under 200k: Orphanet 1-5 / 10 000 (Europe) ≈ 100,499 in the US, under 200,000 (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: Orphanet age of onset: Adolescent, Adult, Childhood, Elderly, Infancy — spans pediatric and adult (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Rimonabant

- Active moiety: RIMONABANT (UNII RML78EN3XE)
- Disease: Obesity
- Indication: As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: licence pulled
- ATC: A08AX01
- Research activity: 10 PubMed papers, 48 registered trials
- ChEMBL indications: Obesity, Cardiovascular Diseases, Metabolic Syndrome, Fatty Liver, Smoking Cessation, Prediabetic State
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Sitaxentan

- Active moiety: SITAXENTAN (UNII J9QH779MEM)
- Disease: Hypertension, Pulmonary
- Indication: Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
- Approved by: EMA; authorised in 0 EEA countries; status: previously_authorised
- Flags: licence pulled
- ATC: C02KX03
- Research activity: 10 PubMed papers, 24 registered trials
- ChEMBL indications: Hypertension, Hypertension, Pulmonary, Renal Insufficiency, Chronic, Proteinuria, Asthma
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [PASS] human evidence exists: published evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))

### Temoporfin

- Active moiety: TEMOPORFIN (UNII FU21S769PF)
- Disease: Head and Neck Neoplasms;Carcinoma, Squamous Cell
- Indication: Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
- Approved by: EMA; authorised in 0 EEA countries; status: authorised
- ATC: L01XD05
- Research activity: 0 PubMed papers, 8 registered trials
- ChEMBL indications: Carcinoma, Squamous Cell, Head and Neck Neoplasms, Neoplasms, Bile Duct Neoplasms, Nasopharyngeal Carcinoma, Carcinoma, Non-Small-Cell Lung
- §529 verdict: LIKELY ELIGIBLE PENDING REVIEW
  - [PASS] no prior us active moiety: no US approval found across UNII variants, string keys and GSRS relatives (s.529(a)(4)(B)(i)(I) / 360ff(a)(4)(B)(i)(I))
  - [UNKNOWN] rare under 200k: US prevalence not supplied; no Orphanet match (a common-disease drug will not match) (s.529(a)(3)(B))
  - [HUMAN] primarily pediatric: no age-of-onset data resolved; must be read from Orphadata (if the disease is listed) or the literature (s.529(a)(3)(A))
  - [HUMAN] serious or life threatening: seriousness not assessed (s.529(a)(3)(A))
  - [HUMAN] qualifies for priority review: requires the US treatment landscape for this exact indication and a view on whether the drug is a significant improvement (s.529(a)(4)(C))
  - [UNKNOWN] human evidence exists: no published human evidence located (505(b)(2) reliance)
  - [HUMAN] filed as 505b1: sponsor's filing decision; note Pub. L. 117-9 (2021) narrowed this to 505(b)(1) only, so a 505(b)(2) repurposing filing forfeits the voucher (s.529(a)(4)(B)(i)(II))
  - [HUMAN] relies on pediatric data: sponsor's filing decision, not a drug property (s.529(a)(4)(D))
  - [HUMAN] no adult indication sought: sponsor's filing decision, not a drug property. Per FDA's 2019 draft guidance (Q5) a label covering adults AND children with the SAME rare pediatric disease is fine (cf. ZANVASTRO 2026-09, Emcitate 2026-09); what (E) bars is a separate adult indication (s.529(a)(4)(E))
  - [UNKNOWN] voucher awardable before sunset: no projected approval date supplied (s.529(b)(5))
  - [UNKNOWN] approved after 30 sep 2016: no projected approval date supplied (s.529(a)(4)(F))