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Lumizyme FDA Approval History

FDA Approved: Yes (First approved May 24, 2010)
Brand name: Lumizyme
Generic name: alglucosidase alfa
Company: Genzyme Corporation
Treatment for: Pompe disease

Lumizyme (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for patients with Pompe disease.

Development timeline for Lumizyme

Aug  1, 2014Approval FDA Expands Approval of Lumizyme to treat Pompe Disease Patients of All Ages
May 25, 2010Approval FDA Approves Lumizyme for Late-Onset Pompe Disease
Jan 21, 2010Genzyme's Lumizyme BLA Receives Six-Month FDA Review
Dec  7, 2009Genzyme to Reopen Enrollment in Alglucosidase Alfa Temporary Access Program
Nov 17, 2009Genzyme Receives Complete Response Letter on Lumizyme Application
May 21, 2009Genzyme Submits All Information Requested by FDA for Lumizyme
Mar  3, 2009Genzyme Receives Complete Response Letter from FDA on Lumizyme Application

Further information

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