TAK

Takeda Pharmaceutical Co., Ltd.

FDA PDUFA Target Action Date

Wednesday, September 2, 2026

99 days away

Drug Information

Drug Name: Rusfertide (CT.gov)
Application Type: NDA
FDA Designations: Priority ReviewBreakthroughOrphan DrugFast Track
Indication: Polycythemia vera (PV)

Filing Details

Company: Takeda Pharmaceutical Co., Ltd. →
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