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OTC Naloxone's Potential Overshadowed As FDA Priortizes Rx Generic Reviews

Executive Summary

FDA appears committed to stemming opioid abuse by accelerating reviews of ANDAs for generics of overdose treatments but acceleration for making one of them, naloxone, available OTC is needed, too, says Michael Hufford, Harm Reduction Therapeutics CEO. "Relief that ... FDA is demonstrating its willingness to do everything that it can to accelerate these approvals," but "frustration that the public continues to be denied access to low cost naloxone," he says.

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US Health Market In 2019: Unfinished Business Leaves Lasting Impression

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

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.

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.

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