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Emergent’s sNDA for NARCAN OTC Gets Priority Review

If approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. for opioid overdose.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Emergent BioSolutions’ supplemental New Drug Application (sNDA) for NARCAN (naloxone HCI) Nasal Spray, as an over-the-counter (OTC) emergency treatment for opioid overdose, has accepted for review by the U.S. FDA. The application was 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.   The opioid epidemic is an ongoing national public health issue and has bee...

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