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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761315
Company: NOVO NORDISK INC

Medication Guide

Products on BLA 761315

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALHEMO	CONCIZUMAB-MTCI	60MG/1.5ML(40MG/ML)	Injectable; Subcutaneous	Prescription	None	No	No
ALHEMO	CONCIZUMAB-MTCI	150MG/1.5ML(100MG/ML)	Injectable; Subcutaneous	Prescription	None	No	No
ALHEMO	CONCIZUMAB-MTCI	300MG/3ML(100MG/ML)	Injectable; Subcutaneous	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761315

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2024	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761315Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761315Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761315s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761315Orig1s003ltr.pdf
05/02/2025	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761315s001lbl.pdf

Labels for BLA 761315

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2025	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761315s003lbl.pdf
07/31/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761315s003lbl.pdf
05/02/2025	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761315s001lbl.pdf
12/20/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf

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