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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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.