FDA — authorised 29 September 2021
- Application: NDA214662
- Marketing authorisation holder: MIRUM
- Status: approved
🇺🇸 Livmarli in United States
FDA authorised Livmarli on 29 September 2021
Marketing authorisations
FDA — authorised 10 April 2025
- Application: NDA219485
- Marketing authorisation holder: MIRUM
- Local brand name: LIVMARLI
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Livmarli in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Livmarli approved in United States?
Yes. FDA authorised it on 29 September 2021; FDA authorised it on 10 April 2025; FDA has authorised it.
Who is the marketing authorisation holder for Livmarli in United States?
MIRUM holds the US marketing authorisation.