Drug application

ALHEMO (CONCIZUMAB)

Drugs@FDA BLA 761428 · NOVO NORDISK INC

Key facts

Drug name ALHEMO
Active ingredients CONCIZUMAB
Application type BLA
Application number 761428
Company NOVO NORDISK INC
Dosage forms SOLUTION, INJECTION
Strength 60MG/1.5ML (40MG/ML)
Marketing status Prescription
Reference listed drug No
Latest submission class Type 9 - New indication submitted as distinct BLA, consolidated
Latest submission status date Jul 31, 2025

At a glance

  • 1–9 Submissions
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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