Bloomberg Law
Feb. 9, 2023, 5:31 PM

Emergent’s Low Narcan Dose Ends as It Asks FDA to Allow OTC Sale

Jeannie Baumann
Jeannie Baumann

Emergent Biosolutions is pulling its application for a lower-dose version of Narcan as the company moves to make a standard dose of the opioid overdose reversal medication available without a prescription.

The Food and Drug Administration announced Thursday it’s withdrawing agency approval of a supplemental new drug application for
a 2 mg nasal spray version of Emergent’s Narcan, according to a Federal Register notice.

Emergent already sells a 4 mg version of Narcan, a brand-name version of naxalone, to reverse an opioid disorder. According to the package insert, providers should only prescribe the 2 mg spray to patients ...

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