Original New Drug Application Approvals by US FDA (01 - 15 November 2022)

15 Nov 2022
Original New Drug Application Approvals by US FDA (01 - 15 November 2022)
New drug applications approved by US FDA as of 01 - 15 November 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, Subcutaneous
  • Company: Astrazeneca AB
  • Approval Date: 10 November 2022
  • Submission Classification: NA
  • Indication(s): Indicated:
    • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
    • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
  • Approved Label:  10 November (PDF)
MIRVETUXIMAB SORAVTANSINE
  • Active Ingredient(s): Mirvetuximab Soravtansine
  • Strength: 100mg/20mL single-dose vial
  • Dosage Form(s) / Route(s): Injectable;Injection
  • Company: Immunogen Inc
  • Approval Date: 14 November 2022
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.  
    This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Approved Label:  14 November (PDF)