Original New Drug Application Approvals by US FDA (1-15 February 2026)

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Original New Drug Application Approvals by US FDA (1-15 February 2026)
New drug applications approved by US FDA as of 1-15 February 2026 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.

VYKOURA
  • Active Ingredient(s): Leucovorin Calcium
  • Strength:50MG/5ML; 350MG/30ML; 500MG/50ML
  • Dosage Form(s) / Route(s): Injectable;intramuscular, Intravenous
  • Company: Avyxa Holdings
  • Approval Date: 3 February 2026
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Rescue after high-dose methotrexate therapy in adult and pediatric patients.
    • Reducing the toxicity of
      • methotrexate in adult and pediatric patients with impaired methotrexate elimination or
      • folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients.
    • Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible.
    • Treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil.
      • Limitations of Use:
      VYKOURA is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12, because of the risk of progression of neurologic manifestations despite hematologic remission.
  • Approved Label:  3 February 2026 (PDF)