FDA — authorised 22 September 2023
- Application: NDA021164
- Marketing authorisation holder: FABRE KRAMER
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 GEPIRONE in United States
FDA authorised GEPIRONE on 22 September 2023
Marketing authorisation
GEPIRONE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is GEPIRONE approved in United States?
Yes. FDA authorised it on 22 September 2023.
Who is the marketing authorisation holder for GEPIRONE in United States?
FABRE KRAMER holds the US marketing authorisation.