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Adapt Pharma Ltd.

www.adaptpharma.com

Latest From Adapt Pharma Ltd.

OTC Naloxone's Potential Overshadowed As FDA Priortizes Rx Generic Reviews

FDA appears committed to stemming opioid abuse by accelerating reviews of ANDAs for generics of overdose treatments but acceleration for making one of them, naloxone, available OTC is needed, too, says Michael Hufford, Harm Reduction Therapeutics CEO. "Relief that ... FDA is demonstrating its willingness to do everything that it can to accelerate these approvals," but "frustration that the public continues to be denied access to low cost naloxone," he says.
Prescription To Otc Switch OTC Drugs

FDA Prioritizes Reviews Of Opioid Overdose ANDAs

Opioid overdose treatments containing naloxone or nalmefene are now eligible for expedited ANDA review in a bid by the FDA to improve patient access.

Regulation Generic Drugs

US FDA Asks Sponsors Of Discontinued Naloxones To Consider Return To Market

In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.

Generic Drugs Neurology

Teva Has Nasal Naloxone Nod For First US Narcan Rival

Teva has received FDA approval for the first US generic naloxone nasal spray after a 30-month stay linked to ongoing patent litigation expired. Launch plans have not yet been revealed. Meanwhile, the Israeli firm has also introduced the first generic version of VESIcare in the US.

Regulation Generic Drugs
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Nasal
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Ireland
  • Parent & Subsidiaries
  • Adapt Pharma Ltd.
  • Senior Management
  • Seamus Mulligan, Chmn. & CEO
    David Brabazon, CFO
    Matt Ruth, Chief Commercial Officer
    Eunan Maguire, COO
    Fintan Keegan, CTO
    Ryan Loughlin, Dir., Drug Dev.
  • Contact Info
  • Adapt Pharma Ltd.
    Phone: 1 -6344-172
    45 Fitzwilliam Sq.
    Dublin 2,
    Ireland
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