The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug or device under consideration. Presented below is a comprehensive list of drugs and devices, along with the anticipated decision date.

Upcoming FDA Decisions for March 2025

  • PDUFA Date: March 6, 2025
    • Furoscix (furosemide injection)
    • scPharmaceuticals Inc.
    • Furoscix seeks an expanded indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD).

  • PDUFA Date: March 6, 2025
    • Neffy
    • ARS Pharmaceuticals
    • Neffy is a needle-free epinephrine nasal spray for severe allergic reactions, seeking approval for the 1 mg targeted for children weighing 15 to 30 kg.

  • PDUFA Date: March 12, 2025
    • Tapinarof (Vtama) cream
    • Organon
    • Tapinarof (Vtama) cream 1% is for patients aged 2 years and older with atopic dermatitis (AD).

  • PDUFA Date: March 18, 2025
    • NT-501 (revakinagene taroretcel)
    • Neurotech Pharmaceuticals, Inc.
    • NT-501 isan investigational encapsulated cell therapy for the treatment of macular telangiectasia type 2 (MacTel).

  • PDUFA Date: March 20, 2025
    • Rivoceranib/Camrelizumab
    • Elevar Therapeutics, Inc.
    • Rivoceranib is an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment  for unresectable or metastatic hepatocellular carcinoma (uHCC).

  • PDUFA Date: March 23, 2025
    • Vutrisiran
    • Alnylam Pharmaceuticals, Inc.
    • Vutrisiran is an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).

  • PDUFA Date: March 26, 2025
    • Gepotidacin 
    • GSK plc
    • Gepotidacin is an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs).

  • PDUFA Date: March 27, 2025
    • Cardamyst (etripamil) nasal spray
    • Milestone Pharmaceuticals Inc.
    • Cardamyst is an investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).

  • PDUFA Date: March 27, 2025
    • DCCR (diazoxide choline)
    • Soleno Therapeutics, Inc
    • DCCR is for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.

  • PDUFA Date: March 28, 2025
    • Fitusiran
    • Alnylam Pharmaceuticals, Inc/Sanofi
    • Fitusiran is an investigational RNAi therapeutic in development for the treatment of hemophilia A and B, with or without inhibitors

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