FDA committee unanimously votes in favor of over-the-counter Narcan from Emergent BioSolutions
16 Feb 2023
The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk pro Narcan. The voters support its use as a nonprescription opioid overdose reversal agent.
Gaithersburg, Maryland-based Emergent presented an overview of its over-the-counter (OTC) development program. It also presented the medical need, human factors study data and seven years of post-marketing safety data. The committees’ guidance does not bind the FDA but the agency will take its advice into consideration.
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