U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761428
Company: NOVO NORDISK INC

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/31/2025 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761428s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761428Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/31/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761428s000lbl.pdf
Back to Top