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FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

 
• By Malcolm Spicer

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.

FDA entrance sign 2016

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.

The agency announced the release of the model DFLs on Jan. 17 along with publication of its review of independent research contractors' study of label comprehension for OTC use of nasal spray and auto-injector products, the two forms of naloxone currently available Rx-only "in consumer-friendly format." The contractors used a prespecified research design with more than 700 participants across a range of potential OTC naloxone users with separate DFLs for a

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