FDA Grants Priority Review To Emergent’s Proposed OTC Naloxone Spray

FDA has granted priority review to Emergent Biosolutions’ proposed over-the-counter version of overdose reversal drug Narcan (naloxone) nasal spray, with a prescription drug user fee goal date of March 29, 2023, the company announced Tuesday (Dec. 6) just one month after FDA announced that certain forms of naloxone may be eligible for nonprescription use in a bid to facilitate development and approval of nonprescription or OTC versions of the drug. Emergent declined to say how much it plans to charge...