🇺🇸 Betaseron in United States

FDA authorised Betaseron on 23 July 1993

Marketing authorisations

FDA — authorised 23 July 1993

  • Application: BLA103471
  • Marketing authorisation holder: BAYER HEALTHCARE PHARMS
  • Status: supplemented

FDA

  • Status: approved

Other Neuroscience approved in United States

Frequently asked questions

Is Betaseron approved in United States?

Yes. FDA authorised it on 23 July 1993; FDA has authorised it.

Who is the marketing authorisation holder for Betaseron in United States?

BAYER HEALTHCARE PHARMS holds the US marketing authorisation.