Naloxone OTC Switch NDA Has US FDA Concerned Labeling Will Cause User Error, Delay Delivery

CDER will ask advisory panel “whether additional labeling information might mitigate risk of use errors” for Emergent’s naloxone nasal spray made available OTC and whether results of firm’s human factors study “support that consumers are able to correctly administer nonprescription [naloxone nasal spray] in an emergency situation.”