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 January 2025
  • AdCom Meeting Date: January 10, 2025
    • Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee
    • The Committee will discuss BLA 761393, condoliase injection submitted by Seikagaku Corp., for the proposed indication of the treatment of radicular leg pain associated with lumbar disc herniation in adults.

  • PDUFA Date: January 2, 2025
    • Vanzacaftor/Tezacaftor/Deutivacaftor (vanza triple)
    • Vertex Pharmaceuticals, Inc.
    • It is a combination therapy for the treatment of cystic fibrosis (CF).

  • PDUFA Date: January 15, 2025
    • Tabelecleucel (tab-cel)
    • Atara Biotherapeutics, Inc.
    • It is an allogeneic, EBV-specific T-cell immunotherapy for the treatment of adult and pediatric patients who are at least 2 years of age with Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease following at least 1 prior therapy.

  • PDUFA Date: January 17, 2025
    • Sotorasib (Lumakras) plus panitumumab (Vectibix)
    • Amgen
    • It is a RAS GTPase family inhibitor for the treatment of chemorefractory metastatic colorectal cancer (CRC) with a KRAS G12C mutation.

  • PDUFA Date: January 29, 2025
    • Datopotamab deruxtecan (Dato-DXd)
    • AstraZeneca/Daiichi Sankyo
    • It is an investigational TROP2-directed ADC for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

  • PDUFA Date: January 29, 2025
    • Elamipretide
    • Stealth BioTherapeutics Inc.
    • It is a novel mitochondrial tetrapeptide for the treatment of Barth syndrome.

  • PDUFA Date: January 30, 2025
    • Suzetrigine
    • Vertex Pharmaceuticals, Inc.
    • It is an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain.

  • PDUFA Date: January 31, 2025
    • MoSEIC meloxicam-rizatriptan (AXS-07)
    • Axsome Therapeutics, Inc.
    • It is a novel, rapidly absorbed investigational medication consisting of molecular solubility enhanced inclusion complex (MoSEIC) meloxicam and rizatriptan that is used for the acute treatment of migraine.

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