FDA — authorised 28 September 2000
- Marketing authorisation holder: DANCO LABS LLC
- Status: approved
🇺🇸 Mifeprex in United States
FDA authorised Mifeprex on 28 September 2000
Marketing authorisations
FDA — authorised 5 November 2019
- Application: NDA202107
- Marketing authorisation holder: CORCEPT THERAP
- Indication: Labeling
- Status: approved
FDA — authorised 3 August 2020
- Application: ANDA211436
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA — authorised 3 January 2023
- Application: ANDA091178
- Marketing authorisation holder: GENBIOPRO
- Indication: REMS
- Status: approved
FDA — authorised 30 September 2025
- Application: ANDA216616
- Marketing authorisation holder: EVITA SOLUTIONS
- Status: approved
Mifeprex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Mifeprex approved in United States?
Yes. FDA authorised it on 28 September 2000; FDA authorised it on 5 November 2019; FDA authorised it on 3 August 2020.
Who is the marketing authorisation holder for Mifeprex in United States?
DANCO LABS LLC holds the US marketing authorisation.