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

02 Mar 2026
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)
ADQUEY
  • Active Ingredient(s): Difamilast
  • Strength: 1%
  • Dosage Form(s) / Route(s): Ointment;topical
  • Company: Acrotech Biopharma
  • Approval Date: 12 February 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.
  • Approved Label:  12 February 2026 (PDF)
AVOPEF
  • Active Ingredient(s): Etoposide
  • Strength: 100MG/5ML
  • Dosage Form(s) / Route(s): Vial; Multidose
  • Company: Avyxa Holdings
  • Approval Date: 13 February 2026
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with:
    • Refractory testicular cancer
    • Small cell lung cancer
  • Approved Label:  13 February 2026 (PDF)
RYBREVANT FASPROI
  • Active Ingredient(s): Amivantamab And Hyaluronidase-lpuj
  • Strength: 1,600MG/20,000 UNITS PER 10ML; 2,240MG/28,000 UNITS PER 14ML; 2,400MG/30,000 UNITS PER 15ML; 3,5200MG/44,000 UNITS PER 22ML
  • Dosage Form(s) / Route(s): Vial; Single-use
  • Company: Janssen Biotech
  • Approval Date: 13 February 2026
  • Submission Classification: NA
  • Indication(s): Indicated:
    • in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
    • in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
    • in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
    • as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
  • Approved Label:  13 February 2026 (PDF)