Lumizyme Approval History beta

  • FDA approved: Yes (First approved May 24th, 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 8 years and older with late (non-infantile) onset Pompe disease.

FDA Approval History for Lumizyme

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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