Original New Drug Application Approvals by US FDA (16-30 April 2025)

29 May 2025
Original New Drug Application Approvals by US FDA (16-30 April 2025)
New drug applications approved by US FDA as of 16-30 April 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.

ELIQUIS
  • Active Ingredient(s): Apixaban
  • Strength: 0.5 MG; 5 MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Bristol
  • Approval Date: 17 April 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
    • for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
    • for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy.
    • Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment
  • Approved Label:  17 April 2025 (PDF)
ELIQUIS SPRINKLE
  • Active Ingredient(s): Apixaban
  • Strength: 0.15 MG
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Bristol
  • Approval Date: 17 April 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
    • for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
    • for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy.
    • Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment
  • Approved Label:  17 April 2025 (PDF)
QAMZOVA
  • Active Ingredient(s): Meloxicam
  • Strength: 30MG/ML (30MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Nanjing Delova
  • Approval Date: 22 April 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.
      • Limitation of Use
      Because of delayed onset of analgesia, QAMZOVA alone is not recommended for use when rapid onset of analgesia is required.
  • Approved Label:  22 April 2025 (PDF)
PENPULIMAB-KCQX
  • Active Ingredient(s): Penpulimab-kcqx
  • Strength: 100MG/10ML(10MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Akeso Biopharma
  • Approval Date: 23 April 2025
  • Submission Classification: NA
  • Indication(s): Indicated:
    • in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma (NPC)
    • as a single agent for the treatment of adults with metastatic nonkeratinizing NPC with disease progression on or after platinumbased chemotherapy and at least one other prior line of therapy
  • Approved Label:  23 April 2025 (PDF)
IMAAVY
  • Active Ingredient(s): Nipocalimab-aahu
  • Strength: 300MG/1.62ML(185MG/ML); 1200MG/6.5ML(185MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Janssen Biotech
  • Approval Date: 29 April 2025
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-musclespecific tyrosine kinase (MuSK) antibody positive.
  • Approved Label:  29 April 2025 (PDF)