FDA — authorised 26 May 2023
- Marketing authorisation holder: LEXICON PHARMS INC
- Status: approved
🇺🇸 Inpefa in United States
FDA authorised Inpefa on 26 May 2023
Marketing authorisations
FDA — authorised 26 May 2023
- Application: NDA216203
- Marketing authorisation holder: LEXICON PHARMS INC
- Local brand name: INPEFA
- Indication: TABLET — ORAL
- Status: approved
Inpefa 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 Inpefa approved in United States?
Yes. FDA authorised it on 26 May 2023; FDA authorised it on 26 May 2023.
Who is the marketing authorisation holder for Inpefa in United States?
LEXICON PHARMS INC holds the US marketing authorisation.