Kaléo Pharmaceutical Inc.
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The prototype pulls information from the electronic record to fill out enrollment and other forms, but stakeholders say it must work for most, if not all, REMS drugs in order to be widely used.
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.
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