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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761052
Company: BIOMARIN PHARM

Products on BLA 761052

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRINEURA	CERLIPONASE ALFA	30MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761052

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2017	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761052Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761052Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761052s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761052Orig1s016ltr.pdf
07/24/2024	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761052s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761052Orig1s014ltr.pdf
03/27/2020	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761052s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761052Orig1s008ltr.pdf
12/06/2019	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761052s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761052Orig1s007ltr.pdf
12/11/2018	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761052s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761052Orig1s003ltr.pdf

Labels for BLA 761052

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2024	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761052s014lbl.pdf
07/10/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761052s016lbl.pdf
03/27/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761052s008lbl.pdf
12/06/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761052s007lbl.pdf
12/11/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761052s003lbl.pdf
04/27/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761052lbl.pdf

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