FDA — authorised 4 December 1961
- Application: NDA012911
- Marketing authorisation holder: ESTEVE
- Local brand name: METOPIRONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Metopirone in United States
FDA authorised Metopirone on 4 December 1961
Marketing authorisation
Metopirone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Metopirone approved in United States?
Yes. FDA authorised it on 4 December 1961.
Who is the marketing authorisation holder for Metopirone in United States?
ESTEVE holds the US marketing authorisation.