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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761051
Company: KYOWA KIRIN

Products on BLA 761051

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTELIGEO	MOGAMULIZUMAB-KPKC	20MG/5ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761051

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761051Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761051Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2026	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761051s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761051Orig1s025ltr.pdf
01/21/2025	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761051s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761051Orig1s018ltr.pdf
03/30/2022	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761051s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761051Orig1s015ltr.pdf
07/08/2021	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761051s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761051Orig1s011ltr.pdf

Labels for BLA 761051

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2026	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761051s025lbl.pdf
01/21/2025	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761051s018lbl.pdf
01/21/2025	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761051s018lbl.pdf
03/30/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761051s015lbl.pdf
07/08/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761051s011lbl.pdf
08/08/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf

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