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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761174
Company: GLAXOSMITHKLINE

Medication Guide

Products on BLA 761174

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JEMPERLI	DOSTARLIMAB-GXLY	500MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761174

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761174Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761174Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761174Orig1s010ltr.pdf
08/01/2024	SUPPL-9	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s009lbl.pdf
07/31/2023	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761174Orig1s006ltr.pdf
02/09/2023	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761174Orig1s003,s004ltr.pdf
02/09/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761174Orig1s003,s004ltr.pdf
04/28/2022	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761174Orig1s002ltr.pdf

Labels for BLA 761174

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2024	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s009lbl.pdf
03/06/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s010lbl.pdf
07/31/2023	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf
02/09/2023	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf
02/09/2023	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf
04/28/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf
04/22/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf

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