FDA — authorised 26 February 2013
- Marketing authorisation holder: SHIONOGI INC
- Status: approved
🇺🇸 Osphena in United States
FDA authorised Osphena on 26 February 2013
Marketing authorisations
FDA — authorised 13 February 2024
- Application: ANDA215574
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: OSPEMIFENE
- Indication: TABLET — ORAL
- Status: approved
Osphena in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Osphena approved in United States?
Yes. FDA authorised it on 26 February 2013; FDA authorised it on 13 February 2024.
Who is the marketing authorisation holder for Osphena in United States?
SHIONOGI INC holds the US marketing authorisation.