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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761334
Company: INCYTE CORP

Medication Guide

Products on BLA 761334

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYNYZ	RETIFANLIMAB-DLWR	500MG/20ML(25MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2023	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761334Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761334Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761334Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2026	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761334s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761334Orig1s008ltr.pdf
12/17/2025	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761334s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761334Orig1s005ltr.pdf
05/15/2025	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761334s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761334Orig1s004ltr.pdf
04/22/2024	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761334s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761334Orig1s002Correctedltr.pdf

Labels for BLA 761334

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2026	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761334s008lbl.pdf
12/17/2025	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761334s005lbl.pdf
05/15/2025	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761334s004lbl.pdf
04/22/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761334s002lbl.pdf
03/22/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761334Orig1s000correctedlbl.pdf

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