FDA underscored its interest in proposals for allowing OTC access to naloxone for treating opioid overdose by taking the unprecedented step of developing model Drug Facts labels that potential sponsors can use for their own label comprehension studies.
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.
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