Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761363
Company: MERCK SHARP DOHME

Products on BLA 761363

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WINREVAIR	SOTATERCEPT-CSRK	45MG	INJECTABLE;INJECTION	Prescription	None	No	No
WINREVAIR	SOTATERCEPT-CSRK	60MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2024	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761363Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761363Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761363s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761363Orig1s008ltr.pdf
10/24/2025	SUPPL-7	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761363Orig1s007ltr.pdf

Labels for BLA 761363

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761363s008lbl.pdf
03/26/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363Orig1s000lbl.pdf