FDA — authorised 10 September 1998
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Arava in United States
FDA authorised Arava on 10 September 1998
Marketing authorisations
FDA — authorised 5 March 2004
- Application: NDA020905
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Efficacy
- Status: approved
FDA — authorised 4 February 2020
- Application: ANDA211863
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 10 May 2021
- Application: ANDA213497
- Marketing authorisation holder: AET PHARMA
- Status: approved
FDA — authorised 23 September 2024
- Application: ANDA091369
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved Arava for labeling indications. This approval was granted to ALEMBIC PHARMS LTD on 2024-09-23. The application number for this approval is ANDA091369.
FDA — authorised 26 September 2024
- Application: ANDA212308
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Labeling
- Status: approved
The FDA approved Arava for labeling indications on September 26, 2024. The marketing authorization holder is ZYDUS LIFESCIENCES. This approval was granted under the standard expedited pathway.
Arava 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 Arava approved in United States?
Yes. FDA authorised it on 10 September 1998; FDA authorised it on 5 March 2004; FDA authorised it on 4 February 2020.
Who is the marketing authorisation holder for Arava in United States?
SANOFI AVENTIS US holds the US marketing authorisation.