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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761261
Company: GENZYME CORP

Products on BLA 761261

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XENPOZYME	OLIPUDASE ALFA-RPCP	20MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761261

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2022	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761261s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761261Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761261Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2024	SUPPL-4	Supplement	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761261s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761261Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761261Orig1s004ltr.pdf
12/05/2023	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761261s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761261Orig1s002ltr.pdf

Labels for BLA 761261

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761261s004lbl.pdf
12/05/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761261s002lbl.pdf
08/31/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761261s000lbl.pdf

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