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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761151
Company: UCB INC

Medication Guide

Products on BLA 761151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIMZELX	BIMEKIZUMAB-BKZX	160ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761151Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761151Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/19/2024	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761151Orig1s010ltr.pdf
10/11/2024	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761151Orig1s009ltr.pdf
09/20/2024	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761151Orig1s005, s006, s007ltr.pdf
09/20/2024	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761151Orig1s005, s006, s007ltr.pdf
09/20/2024	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761151Orig1s005, s006, s007ltr.pdf

Labels for BLA 761151

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/19/2024	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s010lbl.pdf
10/11/2024	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s009lbl.pdf
09/20/2024	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf
09/20/2024	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf
09/20/2024	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf
10/17/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf

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