The company’s naloxone hydrochloride nasal spray can be delivered in one spray by intranasal administration – delivering 4 mg of the drug in adults and pediatric patients – for an initial dosing, according to the FDA label. The regulator’s approval allows its use only when prescribed.
The nod comes at a time when the agency is reviewing applications to also allow over-the-counter use of some naloxone-based drugs, including an application for Emergent Biosolutions’ Narcan.
Late in 2022, the health regulator had said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally and encouraging more manufacturers to seek approval for prescription-free use.
More than 106,000 people died in the United States from drug-involved overdose in 2021, according to government data.
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