Current Report Articles
FDA Approves First Over-the-Counter Naloxone Nasal Spray
FDALogo (March 31, 2023) – The Food and Drug Administration announced on March 29 the agency's approval of Narcan nasal spray (4-milligram naloxone hydrochloride nasal spray) for over-the-counter use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. The FDA's action allows Narcan nasal spray to be sold directly to consumers in pharmacies, convenience stores, grocery stores and gas stations, as well as online. Expected OTC availability, according to Emergent BioSolutions, the manufacturer, is late summer of this year. In the meantime, the prescription product will remain available through current access channels, including pharmacies through standing order or co-prescription laws and through community distribution.
--Karen Braman