Myozyme Approval History
FDA Approved: Yes (First approved April 28, 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
|Apr 28, 2006||Myozyme Approved - Genzyme Corp. - Treatment for Pompe Disease|
|Jan 17, 2006||Genzyme Provides Update on U.S. Marketing Application for Myozyme|
|Jul 29, 2005||Genzyme Submits BLA for Myozyme for Treatment of Pompe Disease|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.