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kaleo Inc.

www.kaleopharma.com

Latest From kaleo Inc.

US FDA's Words Matter: Sharpless Says Injectable Naloxone OK For Community Distribution

The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.

Neurology FDA

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

US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch Proposals

Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Prescription To Otc Switch Consumer
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
  • Therapeutic Areas
  • Immune Disorders
  • Alias(es)
  • Intelliject Inc.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • kaleo Inc.
  • Senior Management
  • T. Spencer Williamson, IV, Pres. & CEO
    Christopher T Schools, CFO
    Kristopher D Ford, VP, Bus. Dev.
    Eric Edwards, MD, PhD, VP, R&D & CMO
  • Contact Info
  • kaleo Inc.
    Phone: (804) 545-6360
    111 Virginia St.
    Ste. 405
    Richmond, VA 23219
    USA
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