Emergent BioSolutions announced the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have unanimously voted in favor that the benefit-risk profile of Narcan Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter, or OTC, development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration.
Published first on TheFly
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