Original-New-Drug-Application-Approvals-by-US-FDA--1-15-April-2025

02 May 2025
Original-New-Drug-Application-Approvals-by-US-FDA--1-15-April-2025
New drug applications approved by US FDA as of 1-15 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.

VANRAFIA
  • Active Ingredient(s): Atrasentan Hydrochloride
  • Strength: 75MG/0.5ML; EQ 0.75MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Novartis
  • Approval Date: 2 April 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
    This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  • Approved Label:  2 April 2025 (PDF)
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
  • Active Ingredient(s): Piperacillin Sodium; Tazobactam Sodium
  • Strength: EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL. EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL. EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL.
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: B Braun Medical Inc
  • Approval Date: 3 April 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of:
    • Intra-abdominal infections in adult and pediatric patients 2 months of age and older
    • Nosocomial pneumonia in adult and pediatric patients 2 months of age and older
    • Skin and skin structure infections in adults
    • Female pelvic infections in adults
    • Community-acquired pneumonia in adults
      Usage to Reduce Development of Drug-Resistant Bacteria
      To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  3 April 2025 (PDF)
LOPRESSOR
  • Active Ingredient(s): Metoprolol Tartrate
  • Strength: 10MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Rubicon
  • Approval Date: 10 April 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adult patients:
    • For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
    • In the long-term treatment of angina pectoris.
    • In the treatment of hemodynamically stable patients with definite or suspected myocardial infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy.
  • Approved Label:  10 April 2025 (PDF)
LIVMARLI
  • Active Ingredient(s): Maralixibat Chloride
  • Strength: EQ 10MG BASE; EQ 15MG BASE; EQ 20MG BASE; EQ 30MG BASE
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Mirum
  • Approval Date: 10 April 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS).
    • the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
      • Limitations of Use:
        LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump (BSEP) protein.
  • Approved Label:  10 April 2025 (PDF)
MEZOFY
  • Active Ingredient(s): Aripiprazole
  • Strength: 5MG; 10MG; 15MG
  • Dosage Form(s) / Route(s): Film;oral
  • Company: Cmg Pharmaceutical Co Ltd
  • Approval Date: 15 April 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of schizophrenia in adult and pediatric patients ages 13 years and older.
  • Approved Label:  15 April 2025 (PDF)

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