FDA Approves First OTC Naloxone Nasal Spray, Generics Must Now Switch

By Beth Wang / March 29, 2023 at 12:12 PM
FDA on Wednesday (March 29) approved Emergent BioSolutions’ 4-milligram over-the-counter Narcan nasal spray -- the first-ever naloxone product to be made available OTC, meaning the medication, which is used to reverse the effects of opioid overdose, can be sold directly to consumers in drug stores, grocery stores, gas stations and online. Manufacturers of generic versions of the product will have to submit supplemental applications to FDA to switch their products to OTC status, as well, the agency said. Generic versions...

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