🇺🇸 Fabrazyme in United States

FDA authorised Fabrazyme on 24 April 2003

Marketing authorisation

FDA — authorised 24 April 2003

  • Application: BLA103979
  • Marketing authorisation holder: GENZYME
  • Local brand name: FABRAZYME
  • Indication: VIAL — INTRAVENOUS
  • Status: approved

The FDA approved Fabrazyme, a product of Genzyme, on 6 February 2024. The approval was granted under the standard expedited pathway. The application number for this approval is BLA103979. The approved indication for Fabrazyme is for its labelling.

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Fabrazyme in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Fabrazyme approved in United States?

Yes. FDA authorised it on 24 April 2003.

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

GENZYME holds the US marketing authorisation.