FDA — authorised 9 July 2021
- Marketing authorisation holder: BAYER HLTHCARE
- Status: approved
🇺🇸 Kerendia in United States
FDA authorised Kerendia on 9 July 2021
Marketing authorisations
FDA — authorised 9 July 2021
- Application: NDA215341
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: KERENDIA
- Indication: TABLET — ORAL
- Status: approved
Kerendia 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 Kerendia approved in United States?
Yes. FDA authorised it on 9 July 2021; FDA authorised it on 9 July 2021.
Who is the marketing authorisation holder for Kerendia in United States?
BAYER HLTHCARE holds the US marketing authorisation.