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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761467
Company: MERCK SHARP DOHME

Medication Guide

Products on BLA 761467

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEYTRUDA QLEX	PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH	395MG/4800UNITS(2.4ML)	INJECTABLE;INJECTION	Prescription	None	No	No
KEYTRUDA QLEX	PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH	790MG/9600UNITS(4.8ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761467

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2025	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761467Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761467Orig1,Orig2s000TOC.html
09/19/2025	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761467Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761467Orig1,Orig2s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2026	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761467Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761467Orig1s002ltr.pdf
11/21/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761467Orig1s001ltr.pdf

Labels for BLA 761467

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2026	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761467Orig1s002lbl.pdf
11/21/2025	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s001lbl.pdf
09/19/2025	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig2.pdf
09/19/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig1.pdf

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