The Approval of Over-the-Counter Narcan Nasal Spray

Released: 04/14/2023  

The approval of over-the counter Narcan nasal spray 

The U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray, for over-the counter (OTC) use.  This is the first naloxone product approved for use without a prescription.  Naloxone is a medication that rapidly reverses the effects of opioid overdose in minutes and is the standard treatment for opioid overdose. 

Naloxone is available in an injectable form and in other doses. The other dosages and formulations of naloxone will remain available by prescription only. 

Narcan is manufactured by Emergent BioSolutions. The drug company anticipates the nasal spray will be available on store shelves and at online retailers by late summer. It is unknown at this time how much the product will cost. 

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