Kaléo Pharmaceutical Inc.
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Latest From Kaléo Pharmaceutical Inc.
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.
The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.
Opioid overdose treatments containing naloxone or nalmefene are now eligible for expedited ANDA review in a bid by the FDA to improve patient access.
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.
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