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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125291
Company: GENZYME

Summary Review

Products on BLA 125291

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMIZYME	ALGLUCOSIDASE ALFA	5MG/ML	POWDER; IV (INFUSION)	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125291

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2010	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125291s000ltrR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2024	SUPPL-160	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125291s160lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125291Orig1s160ltr.pdf
05/24/2023	SUPPL-159	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125291s159lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125291Orig1s159ltr.pdf
05/12/2022	SUPPL-157	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125291s156s157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125291Orig1s156, s157ltr.pdf
05/12/2022	SUPPL-156	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125291s156s157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125291Orig1s156, s157ltr.pdf
02/18/2020	SUPPL-151	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125291s151lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125141Orig1s223,125291Orig1s151ltr.pdf
05/30/2019	SUPPL-148	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125291s148lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125141Orig1s222, 125291Orig1s148ltr.pdf
08/01/2014	SUPPL-136	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s136ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125291Orig1s136.pdf
05/22/2014	SUPPL-133	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s133ltr.pdf
07/16/2012	SUPPL-79	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Origs0079ltr.pdf
07/09/2012	SUPPL-63	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125291s0063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Orig1s0063ltr.pdf
09/12/2011	SUPPL-43	Supplement		Label is not available on this site.

Labels for BLA 125291

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2024	SUPPL-160	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125291s160lbl.pdf
05/24/2023	SUPPL-159	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125291s159lbl.pdf
05/12/2022	SUPPL-157	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125291s156s157lbl.pdf
05/12/2022	SUPPL-156	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125291s156s157lbl.pdf
02/18/2020	SUPPL-151	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125291s151lbl.pdf
05/30/2019	SUPPL-148	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125291s148lbl.pdf
08/01/2014	SUPPL-136	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s136lbl.pdf
05/22/2014	SUPPL-133	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf
07/09/2012	SUPPL-63	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125291s0063lbl.pdf
05/24/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf

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