Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125141
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYOZYME ALGLUCOSIDASE ALFA 20MG/KG INJECTABLE; IV (INFUSION) Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/28/2006 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125141s0_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125141s000_MyozymeTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2020 SUPPL-223 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125141s223lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125141Orig1s223,125291Orig1s151ltr.pdf
05/30/2019 SUPPL-222 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125141s222lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125141Orig1s222, 125291Orig1s148ltr.pdf
05/20/2014 SUPPL-219 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125141Orig1s219ltr.pdf
07/09/2012 SUPPL-176 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125141Orig1s0176ltr.pdf
06/11/2010 SUPPL-116 Supplement

Label is not available on this site.

12/08/2008 SUPPL-74 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125141s074ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/18/2020 SUPPL-223 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125141s223lbl.pdf
05/30/2019 SUPPL-222 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125141s222lbl.pdf
05/20/2014 SUPPL-219 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf
07/09/2012 SUPPL-176 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf
12/08/2008 SUPPL-74 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf
04/28/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf

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