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 July 2024

  • AdCom Meeting Date: July 25, 2024
    • IMFINZI (durvalumab) injection
    • AstraZeneca
    • The proposed indication is IMFINZI in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC). The Committee will also be asked to discuss whether drug sponsors should be required to adequately justify treatment of patients both before and after surgery for resectable NSCLC prior to an approval that would include both neoadjuvant and adjuvant therapy.
  • PDUFA Date: July 7, 2024
    • Roflumilast cream 0.15%
    • Arcutis Biotherapeutics, Inc.
    • Roflumilast cream is a once-daily, steroid-free, phosphodiesterase-4 (PDE4) inhibitor for the treatment of atopic dermatitis (AD) in adults and children down to age 6.
  • PDUFA Date: July 15, 2024
    • OX124
    • Orexo
    • OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s drug delivery platform, amorphOX®.
  • PDUFA Date: July 19, 2024
    • Vonoprazan
    • Phathom Pharmaceuticals, Inc.
    • Vonoprazan is an oral small molecule potassium-competitive acid blocker used for the treatment of heartburn associated with nonerosive gastroesophageal reflux disease (NERD) in adults.
  • PDUFA Date: July 27, 2024
    • ALPHA-1062
    • Alpha Cognition
    • ALPHA-1062 is a prodrug of an approved acetylcholinesterase inhibitor (AChEI), galantamine. It is for the treatment of mild-to-moderate Alzheimer’s Disease.

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