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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761158
Company: GLAXOSMITHKLINE

Medication Guide

Products on BLA 761158

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BLENREP	BELANTAMAB MAFODOTIN-BLMF	2.5MG/KG	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761158

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761158Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761158Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2021	SUPPL-7	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761158Orig1s007ltr.pdf
02/28/2022	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761158s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761158Orig1s006ltr.pdf
11/20/2020	SUPPL-3	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761158Orig1s003ltr.pdf

Labels for BLA 761158

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2022	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761158s006lbl.pdf
02/28/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761158s006lbl.pdf
08/05/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf

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