TAK

Oveporexton (TAK-861)

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

Monday, August 10, 2026

Approved

approved

Note: Approved 2026-08-05 as ORZEYFUL (ORIG NDA220860). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-28; 5d from the PDUFA date.

Drug Information

Drug Name: Oveporexton (TAK-861) (CT.gov)
Application Type: NDA
FDA Designations: Priority ReviewBreakthrough
Indication: Narcolepsy type 1 (excessive daytime sleepiness)
Approved As: Oveporexton (TAK-861)

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