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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761197
Company: GENENTECH INC

Medication Guide

Products on BLA 761197

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUSVIMO	RANIBIZUMAB	100MG/ML	SOLUTION;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761197Orig1s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761197Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761197s008ltr.pdf
05/21/2025	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761197Orig1s007ltr.pdf
02/03/2025	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761197Orig1s006ltr.pdf
04/18/2022	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761197s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761197Orig1s002ltr.pdf

Labels for BLA 761197

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s008lbl.pdf
05/21/2025	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s007lbl.pdf
02/03/2025	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s006lbl.pdf
04/18/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761197s002lbl.pdf
10/22/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf

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