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Myozyme Approval History

  • FDA approved: Yes (First approved April 28th, 2006)
  • Brand name: Myozyme
  • Generic name: alglucosidase alfa
  • Company: Genzyme Corp.
  • Treatment for: Pompe disease

Myozyme is a recombinant formulation of the human enzyme acid alpha-glucosidase (GAA) indicated for use in patients with Pompe disease (GAA deficiency), a debilitating and often fatal muscle disorder.

Development History and FDA Approval Process for Myozyme

DateArticle
Apr 28, 2006Approval Myozyme Approved - Genzyme Corp. - Treatment for Pompe Disease
Jan 17, 2006Genzyme Provides Update on U.S. Marketing Application for Myozyme
Jul 29, 2005Genzyme Submits BLA for Myozyme for Treatment of Pompe Disease

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