FDA — authorised 16 July 2021
- Marketing authorisation holder: SANOFI
- Status: approved
🇺🇸 Fexinidazole in United States
FDA authorised Fexinidazole on 16 July 2021
Marketing authorisations
FDA — authorised 16 July 2021
- Application: NDA214429
- Marketing authorisation holder: SANOFI
- Local brand name: FEXINIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
Fexinidazole in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Fexinidazole approved in United States?
Yes. FDA authorised it on 16 July 2021; FDA authorised it on 16 July 2021.
Who is the marketing authorisation holder for Fexinidazole in United States?
SANOFI holds the US marketing authorisation.