Original New Drug Application Approvals by US FDA (16 - 31 October 2022)

02 Nov 2022
Original New Drug Application Approvals by US FDA (16 - 31 October 2022)
New drug applications approved by US FDA as of 15 - 31 October 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

IMJUDO
  • Active Ingredient(s): Tremelimumab-actl
  • Strength: 25MG/1.25ML(20MG/ML); 300MG/15ML(20MG/ML)
  • Dosage Form(s) / Route(s): Injectable;Intravenous
  • Company: Astrazeneca Ab
  • Approval Date: 21 October 2022
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
  • Approved Label:  21 October (PDF)
TECVAYLI
  • Active Ingredient(s): Teclistamab-cqyv
  • Strength: 30MG/3ML(10MG/ML); 153MG/1.7ML(90MG/ML)
  • Dosage Form(s) / Route(s): Injectable;Injection
  • Company: Janssen Biotech
  • Approval Date: 25 October 2022
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

    This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label:  25 October (PDF)