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OTC Switch For Naloxone Finding Interest Among Sponsors

Executive Summary

With FDA 'si label comprehension study near completion, sponsors seem more positive about OTC versions of naloxone products. FDA has made clear it is interested in switching the product from Rx-only but had trouble generating sponsor desire to develop it.

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

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.

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.

Cost Concerns May Hinder Naloxone Co-Prescribing Ideas

US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.

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