FDA — authorised 12 September 2012
- Application: NDA202992
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AUBAGIO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Teriflunomide HMR1726 in United States
FDA authorised Teriflunomide HMR1726 on 12 September 2012
Marketing authorisation
Teriflunomide HMR1726 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Teriflunomide HMR1726 approved in United States?
Yes. FDA authorised it on 12 September 2012.
Who is the marketing authorisation holder for Teriflunomide HMR1726 in United States?
SANOFI AVENTIS US holds the US marketing authorisation.