FDA — authorised 12 September 2012
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Aubagio in United States
FDA authorised Aubagio on 12 September 2012
Marketing authorisations
FDA — authorised 30 April 2021
- Application: NDA202992
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Efficacy
- Status: approved
FDA — authorised 7 October 2022
- Application: ANDA209572
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 13 March 2023
- Application: ANDA209598
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 15 May 2023
- Application: ANDA209555
- Marketing authorisation holder: NATCO
- Status: approved
FDA — authorised 7 April 2025
- Application: ANDA218663
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Status: approved
Aubagio in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Aubagio approved in United States?
Yes. FDA authorised it on 12 September 2012; FDA authorised it on 30 April 2021; FDA authorised it on 7 October 2022.
Who is the marketing authorisation holder for Aubagio in United States?
SANOFI AVENTIS US holds the US marketing authorisation.