FDA — authorised 2 November 1998
- Marketing authorisation holder: IMMUNEX
- Status: approved
🇺🇸 Enbrel in United States
FDA authorised Enbrel on 2 November 1998
Marketing authorisations
FDA — authorised 31 October 2007
- Application: BLA103795
- Marketing authorisation holder: IMMUNEX
- Indication: Supplement
- Status: approved
Enbrel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Enbrel approved in United States?
Yes. FDA authorised it on 2 November 1998; FDA authorised it on 31 October 2007.
Who is the marketing authorisation holder for Enbrel in United States?
IMMUNEX holds the US marketing authorisation.