🇺🇸 Avonex in United States

FDA authorised Avonex on 17 May 1996

Marketing authorisations

FDA — authorised 17 May 1996

  • Marketing authorisation holder: BIOGEN
  • Status: approved

FDA — authorised 23 February 2005

  • Application: BLA103628
  • Marketing authorisation holder: BIOGEN
  • Indication: Labeling
  • Status: approved

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FDA — authorised 26 May 2020

  • Application: BLA103780
  • Marketing authorisation holder: SERONO INC
  • Indication: Efficacy
  • Status: approved

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Avonex in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in United States

Frequently asked questions

Is Avonex approved in United States?

Yes. FDA authorised it on 17 May 1996; FDA authorised it on 23 February 2005; FDA authorised it on 26 May 2020.

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

BIOGEN holds the US marketing authorisation.