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Kaléo Pharmaceutical Inc.

http://www.kaleopharma.com/

Latest From Kaléo Pharmaceutical Inc.

Ohio Study Shows Access To Naloxone Soars Without Rx Requirement

JAMA study finds that removing Rx requirement for naloxone in Ohio resulted in a 2,328% increase in orders of the drug dispensed since 2015. Michael Hufford, CEO of a company working on an OTC switch for a naloxone nasal spray, says the results show urgent need for a low-cost OTC product.

OTC Drugs Drug Approval Standards

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
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
    • Specialty Pharmaceuticals
  • Other Names / Subsidiaries
    • Intelliject, Inc.
    • IJ Therapeutics
    • Kaléo, Inc.
    • Kaleo
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