ROIV
Brepocitinib
FDA PDUFA Target Action Date · Roivant Sciences Ltd.
Wednesday, September 30, 2026
Approved
approved Note: Approved 2026-08-27 as LISRAYA (ORIG NDA220106). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 34d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
Drug Information
- Drug Name
- Brepocitinib (CT.gov)
- Application Type
- NDA
- FDA Designations
- BreakthroughOrphan DrugPriority Review
- Indication
- Dermatomyositis
- Approved As
- Brepocitinib
Filing Details
- Company
- Roivant Sciences Ltd.
- Stock Ticker
- ROIV
- SEC CIK
- 0001635088
- Source
- GlobeNewswire →
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
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue