Original New Drug Application Approvals by US FDA (16-30 April 2025)
29 May 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
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)
- 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)
- 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.
- Approved Label: 22 April 2025 (PDF)
- Limitation of Use
Because of delayed onset of analgesia, QAMZOVA alone is not recommended for use when rapid onset of analgesia is required.
- 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)
- 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)
