Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

29 May 2025
Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025
New drug applications approved by US FDA as of 1-15 May 2025 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.

BREKIYA
  • Active Ingredient(s): Dihydroergotamine Mesylate
  • Strength: 1 MG/ML
  • Dosage Form(s) / Route(s): Solution;subcutaneous
  • Company: Amneal
  • Approval Date: 14 May 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.
    • Limitations of Use
    BREKIYA is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura.
  • Approved Label:  14 May 2025 (PDF)
EMRELIS
  • Active Ingredient(s): Telisotuzumab Vedotin-tllv
  • Strength: 20MG; 100MG
  • Dosage Form(s) / Route(s): Vial;single-dose
  • Company: Abbvie Inc
  • Approval Date: 14 May 2025
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
    This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label:  14 May 2025 (PDF)