Emergent BioSolutions announced that the U.S. FDA has accepted for review its supplemental New Drug Application for Narcan Nasal Spray, as an over-the-counter emergency treatment for known or suspected opioid overdose. The application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023.
Published first on TheFly
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