Original New Drug Application Approvals by US FDA (16-28 February 2025)

14 Mar 2025
Original New Drug Application Approvals by US FDA (16-28 February 2025)
New drug applications approved by US FDA as of 16-28 February 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.

NILOTINIB D-TARTRATE
  • Active Ingredient(s): Nilotinib D-tartrate
  • Strength: EQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Cipla
  • Approval Date: 19 February 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
    • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
  • Approved Label:  19 February 2025 (PDF)
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
  • Active Ingredient(s): Diltiazem Hydrochloride
  • Strength: 100MG/100ML (1MG/ML); 250MG/250ML (1MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Hq Spclt Pharma
  • Approval Date: 21 February 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the following:
    • Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.
    • Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
  • Approved Label:  21 February 2025 (PDF)
CTEXLI
  • Active Ingredient(s): Chenodiol
  • Strength: 250 MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Mirum
  • Approval Date: 21 February 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for treatment of cerebrotendinous xanthomatosis (CTX) in adults.
  • Approved Label:  21 February 2025 (PDF)
MIUDELLA
  • Active Ingredient(s): Copper
  • Strength: 175MM(2)
  • Dosage Form(s) / Route(s): System;intrauterine
  • Company: Sebela Womens Health Inc
  • Approval Date: 24 February 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.
  • Approved Label:  24 February 2025 (PDF)
EPINEPHRINE
  • Active Ingredient(s): Epinephrine;sodiumchloride
  • Strength: 16MG;250ML(9%)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Baxter Hlthcare Corp
  • Approval Date: 28 February 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
  • Approved Label:  28 February 2025 (PDF)
OSENVELT
  • Active Ingredient(s): Denosumab-bmwo
  • Strength: 120MG/1.7ML(70MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Celltrion Inc
  • Approval Date: 28 February 2025
  • Submission Classification: NA
  • Indication(s): Indicated for:
    • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
    • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
    • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
  • Approved Label:  28 February 2025 (PDF)
STOBOCLO
  • Active Ingredient(s): Denosumab-bmwo
  • Strength: 60MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Celltrion Inc
  • Approval Date: 28 February 2025
  • Submission Classification: NA
  • Indication(s): Indicated for treatment:
    • of postmenopausal women with osteoporosis at high risk for fracture
    • to increase bone mass in men with osteoporosis at high risk for fracture
    • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
    • to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
    • to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
  • Approved Label:  28 February 2025 (PDF)