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kaleo Inc.

www.kaleopharma.com

Latest From kaleo Inc.

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

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

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. 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 Regulation

OTC Switch For Naloxone Finding Interest Among Sponsors

Now that US FDA is about to complete label comprehension study, sponsors seem more positive about OTC versions of naloxone products.
Advisory Committees Prescription To Otc Switch

OTC Switch For Naloxone Finding Interest Among Sponsors

With FDA 'si label comprehension study near completion, sponsors seem more positive about OTC versions of naloxone products. FDA has made clear it is interested in switching the product from Rx-only but had trouble generating sponsor desire to develop it.

Advisory Committees Prescription To Otc Switch
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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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