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.

US FDA will publish a model OTC naloxone Drug Facts label “soon” to help switch sponsors developing labeling comprehension studies and final labeling, says Commissioner Scott Gottlieb.

The agency’s work on a Drug Facts label (DFL) for naloxone reflects its encouragement to drug companies to submit Rx-to-OTC...