The FDA announced that it has approved an Rx to OTC switch for Amphastar Pharmaceutical’s Rextovy 4 mg naloxone nasal spray. Amphastar’s naloxone nasal spray was initially approved for the treatment of opioid overdose by prescription only in 2023. Other 4 mg naloxone nasal sprays already available over the counter include Emergent’s Narcan and generics from Amneal, Padagis, and Teva.
Acting Director of the FDA’s Center for Drug Evaluation and Research Mike Davis commented, “Reducing opioid overdose deaths is a top priority for FDA. Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives.”
Director of CDER’s Office of Nonprescription Drug Products Karen Murry added, “Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available. We are proud of the dedicated work our review divisions put into making this approval possible, and we encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”
Read the FDA press release
