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Prescription To Otc Switch Consumer Advertising, Marketing & Sales

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

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Executive Summary

Development of the model DFLs was a first for agency. 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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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