Application 761363
- Type
- BLA
- Sponsor
- MERCK SHARP DOHME
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761363 | Winrevair | sotatercept-csrk | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 45MG | No | No |
| 002 | WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 60MG | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85547 | SUPPL | 2026-03-27 |
| 85546 | SUPPL | 2026-03-27 |
| 84438 | SUPPL | 2025-12-18 |
| 84364 | SUPPL | 2025-12-09 |
| 83960 | SUPPL | 2025-10-28 |
| 77980 | ORIG | 2024-09-24 |
| 78413 | ORIG | 2024-05-07 |
| 78000 | ORIG | 2024-03-27 |