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FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap

Executive Summary

CDER has been studying ideas such as pictograms to communicate instructions on administering opioid-reversal medication, but officials can’t predict when new approaches might help enable FDA to propose regulatory changes in the US switch process.

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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.

Naloxone Model OTC Label Expected From US FDA As Part Of Opioids Strategy

US FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees meet in December to discuss proposed routes to make the opioid overdose reversal agent naloxone more available: both as an OTC product and one co-prescribed with opioids.

Naloxone Model OTC Label Expected From US FDA As Part Of Opioids Strategy

US FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees meet in December to discuss proposed routes to make the opioid overdose reversal agent naloxone more available: both as an OTC product and one co-prescribed with opioids.

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