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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761125
Company: NOVARTIS PHARMS CORP

Products on BLA 761125

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEOVU	brolucizumab-dbll	6MG/0.05ML	INJECTABLE; INTRAVITREAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761125

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761125s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761125Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761125_Orig1_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2023	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761125s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761125Orig1s020ltr.pdf
12/19/2022	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761125Orig1s017ltr.pdf
02/18/2022	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761125Orig1s010, s012, s013ltr.pdf
02/18/2022	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761125Orig1s010, s012, s013ltr.pdf
02/18/2022	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761125Orig1s010, s012, s013ltr.pdf
05/27/2022	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761125Orig1s008ltr.pdf
06/09/2020	SUPPL-4	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761125s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761125Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761125Orig1s004.pdf
03/09/2022	SUPPL-2	Supplement		Label is not available on this site.

Labels for BLA 761125

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761125s020lbl.pdf
12/19/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s017lbl.pdf
05/27/2022	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s008lbl.pdf
02/18/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s013lbl.pdf
02/18/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s013lbl.pdf
02/18/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761125s010s012s013lbl.pdf
06/09/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761125s004lbl.pdf
10/07/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761125s000lbl.pdf

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