FDA Signals Support for OTC Naloxone in Response to Opioid Crisis

FDA Signals Support for OTC Naloxone in Response to Opioid Crisis

In a statement issued on January 17, 2019, US Food and Drug Administration Commissioner Scott Gottlieb, MD announced steps being taken by FDA to support the development and launch of over-the-counter (OTC) formulations of naloxone to help reduce opioid overdose deaths.  In the announcement, Dr. Gottlieb referenced the rising number of opioid-related deaths, and commented on the importance of naloxone access in addressing that public health crisis. 

To encourage drug companies to quickly bring both injectable and nasal formulations of naloxone to the market as OTC products, the FDA has issued model "drug facts" labels that can be used by potential manufacturers.  FDA also conducted extensive testing to ensure the "consumer-friendly" instructions are simple to follow.  Providing these resources will reduce significant barriers to the launch of OTC naloxone, and clearly signals the FDA position on the acceptability of the conversion of naloxone to OTC status.


More information on the Commissioner’s comments can be found on the FDA web site using this link.

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