FDA — authorised 23 November 2004
- Marketing authorisation holder: BIOGEN IDEC
- Status: approved
🇺🇸 Tysabri in United States
FDA authorised Tysabri on 23 November 2004
Marketing authorisations
FDA — authorised 17 June 2020
- Application: BLA125104
- Marketing authorisation holder: BIOGEN IDEC
- Indication: Labeling
- Status: approved
FDA — authorised 2 February 2026
- Application: BLA761322
- Marketing authorisation holder: SANDOZ INC
- Indication: REMS
- Status: approved
Sandoz Inc. received marketing authorisation from the FDA for Tysabri on 2 February 2026. The approval was granted under the standard expedited pathway. The approved indication for Tysabri is under a Risk Evaluation and Mitigation Strategy (REMS).
Tysabri 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 Tysabri approved in United States?
Yes. FDA authorised it on 23 November 2004; FDA authorised it on 17 June 2020; FDA authorised it on 2 February 2026.
Who is the marketing authorisation holder for Tysabri in United States?
BIOGEN IDEC holds the US marketing authorisation.