FDA — authorised 27 May 2016
- Marketing authorisation holder: INTERCEPT PHARMACEUTICALS INC
- Status: approved
🇺🇸 Ocaliva in United States
FDA authorised Ocaliva on 27 May 2016
Marketing authorisations
FDA — authorised 27 May 2016
- Application: NDA207999
- Marketing authorisation holder: INTERCEPT PHARMS INC
- Local brand name: OCALIVA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2023
- Application: ANDA215017
- Marketing authorisation holder: MSN
- Local brand name: OBETICHOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2023
- Application: ANDA214862
- Marketing authorisation holder: APOTEX
- Local brand name: OBETICHOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2023
- Application: ANDA214980
- Marketing authorisation holder: LUPIN
- Local brand name: OBETICHOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214935
- Marketing authorisation holder: OPTIMUS PHARMA PRIVATE LTD
- Local brand name: OBETICHOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
Ocaliva 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 Ocaliva approved in United States?
Yes. FDA authorised it on 27 May 2016; FDA authorised it on 27 May 2016; FDA authorised it on 30 May 2023.
Who is the marketing authorisation holder for Ocaliva in United States?
INTERCEPT PHARMACEUTICALS INC holds the US marketing authorisation.