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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103979
Company: GENZYME

Products on BLA 103979

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FABRAZYME	AGALSIDASE BETA	5MG/VIAL	VIAL; INTRAVENOUS	Prescription	None	No	No
FABRAZYME	AGALSIDASE BETA	35MG/VIAL	VIAL; INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103979

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/2003	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf https://web.archive.org/web/20170202073410/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm128159.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103979_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2024	SUPPL-5312	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103979s5312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103979Orig1s5312ltr.pdf
03/11/2021	SUPPL-5309	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103979s5309lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103979Orig1s5309ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/103979Orig1s5309.pdf
11/01/2019	SUPPL-5306	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103979Orig1s5306ltr.pdf
12/18/2018	SUPPL-5303	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103979Orig1s5303ltr.pdf
05/14/2010	SUPPL-5135	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf
12/17/2008	SUPPL-5107	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103979s5107ltr.pdf
09/29/2006	SUPPL-5066	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf
09/29/2006	SUPPL-5065	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf
09/29/2006	SUPPL-5058	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf

Labels for BLA 103979

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2024	SUPPL-5312	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103979s5312lbl.pdf
03/11/2021	SUPPL-5309	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103979s5309lbl.pdf
12/18/2018	SUPPL-5303	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf
12/18/2018	SUPPL-5303	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf
05/14/2010	SUPPL-5135	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf
12/17/2008	SUPPL-5107	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf
09/29/2006	SUPPL-5066	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf
09/29/2006	SUPPL-5065	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf
09/29/2006	SUPPL-5058	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf
04/24/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf

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