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DECEMBER 28, 2022

FDA Accepts sNDA, Gives Priority Review to OTC Naloxone Nasal Spray

The FDA accepted and granted priority review to a supplemental New Drug Application for an over-the-counter version of naloxone hydrochloride nasal spray (Narcan, Emergent BioSolutions) for known or suspected opioid overdose. If approved, it would be the first 4-mg naloxone nasal spray available over the counter in the United States. The Prescription Drug User Fee Act goal date is March 29, 2023.

Naloxone HCI nasal spray 4 mg was the first intranasal form of naloxone approved by the FDA in 2015.