Approval covers the treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This market the first such authorization for this type of spray in healthcare and community use.
The FDA nod comes on the heels of the March authorization of over-the-counter Narcan. Narcan (naloxone hydrochloride) rapidly reverses the effects of opioid overdose and remains the standard treatment for such an overdose. The nasal spray first received FDA approval in 2015 as a prescription drug.
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