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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761309
Company: GENENTECH INC

Medication Guide

Products on BLA 761309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLUMVI	GLOFITAMAB-GXBM	2.5MG/2.5ML(1MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
COLUMVI	GLOFITAMAB-GXBM	10MG/10ML(1MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761309Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761309Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2026	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761309s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761309Orig1s007ltr.pdf
05/28/2026	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761309s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761309Orig1s006ltr.pdf
10/27/2025	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761309s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761309Orig1s004ltr.pdf
06/09/2025	SUPPL-3	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761309s003lbl.pdf

Labels for BLA 761309

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2026	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761309s007lbl.pdf
06/22/2026	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761309s007lbl.pdf
05/28/2026	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761309s006lbl.pdf
10/27/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761309s004lbl.pdf
06/09/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761309s003lbl.pdf
06/15/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf

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