An FDA study on expanding access to opioid overdose-reversal medication could suggest a model for Rx-to-OTC switch proposals that include some form of extra-label information, though the agency isn't going so far as saying the results will facilitate approvals for more nonprescription ingredients.
FDA Center for Drug Evaluation and Research officials said during an industry conference on May 11-12 that the agency for one year has been developing and testing labeling that instructs consumers on administering the opioid receptor antagonist naloxone through intramuscular injection or nasal delivery to a person