TheraRadar
TAK

Rusfertide

FDA PDUFA Target Action Date · Takeda Pharmaceutical Co., Ltd.

Monday, August 31, 2026
Approved
approved

Note: Approved 2026-08-28 as MIMRYLO (ORIG NDA220605). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 3d from the PDUFA date.

Drug Information

Application Type
NDA
FDA Designations
Priority ReviewBreakthroughOrphan DrugFast Track
Indication
Polycythemia vera (PV)
Approved As
Rusfertide

Filing Details

Stock Ticker
TAK
SEC CIK
0001395064

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