Monday, September 21, 2026
Approved
approved Note: Approved 2026-09-21 as WINREVAIR (SUPPL BLA761363). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Drug Information
- Drug Name
- Winrevair (sotatercept) (CT.gov)
- Application Type
- sBLA
- Indication
- Recently diagnosed pulmonary arterial hypertension (PAH, HYPERION label update)
- Approved As
- Winrevair (sotatercept)
Filing Details
- Company
- Merck & Co., Inc. →
- Stock Ticker
- MRK
- SEC CIK
- 0000310158
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue