FDA — authorised 25 June 2020
- Marketing authorisation holder: UCB INC
- Status: approved
🇺🇸 Fintepla in United States
FDA authorised Fintepla on 25 June 2020
Marketing authorisations
FDA — authorised 25 June 2020
- Application: NDA212102
- Marketing authorisation holder: UCB INC
- Local brand name: FINTEPLA
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA216108
- Marketing authorisation holder: APOTEX INC
- Local brand name: FENFLURAMINE
- Indication: SOLUTION — ORAL
- Status: approved
Fintepla 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 Fintepla approved in United States?
Yes. FDA authorised it on 25 June 2020; FDA authorised it on 25 June 2020; FDA has authorised it.
Who is the marketing authorisation holder for Fintepla in United States?
UCB INC holds the US marketing authorisation.