Monday, August 31, 2026
Approved August 5, 2026
approved Drug Information
- Drug Name
- Rusfertide (CT.gov)
- Application Type
- NDA
- FDA Designations
- Priority ReviewBreakthroughOrphan DrugFast Track
- Indication
- Polycythemia vera (PV)
- Approved As
- ORZEYFUL →
Filing Details
- Stock Ticker
- TAK
- SEC CIK
- 0001395064
- 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