Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761235
Company: GENENTECH INC

Products on BLA 761235

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VABYSMO	FARICIMAB-SVOA	120MG/ML	INJECTABLE; INTRAVITREAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2022	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761235Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761235Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761235Orig1s003ltr.pdf
01/27/2023	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761235Orig1s001ltr.pdf

Labels for BLA 761235

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf
01/27/2023	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s001lbl.pdf
01/28/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf