FDA Explores Approving OTC Naloxone Products

The U.S. Food and Drug Administration (FDA) has announced a potential pathway to allow naloxone hydrochloride, known by the name brand Narcan, to be approved for over-the-counter use.

The Nov. 15 Federal Register notice, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” stated that the proposal would result in greater access to naloxone, a life-saving medication, that may prevent overdose deaths from opioids such as heroin, fentanyl and prescription opioid medications. Naloxone is easy to use and small to carry.

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