FDA — authorised 23 July 1993
- Marketing authorisation holder: BAYER HEALTHCARE PHARMS
- Status: approved
🇺🇸 Betaseron in United States
FDA authorised Betaseron on 23 July 1993
Marketing authorisations
FDA — authorised 28 July 2005
- Application: BLA103471
- Marketing authorisation holder: BAYER HEALTHCARE PHARMS
- Indication: Supplement
- Status: approved
Betaseron 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 Betaseron approved in United States?
Yes. FDA authorised it on 23 July 1993; FDA authorised it on 28 July 2005.
Who is the marketing authorisation holder for Betaseron in United States?
BAYER HEALTHCARE PHARMS holds the US marketing authorisation.