Emergent BioSolutions said Tuesday that the FDA will decide whether to approve its OTC nasal spray by late March 2023.
. But experts have long argued that making it possible for naloxone to be sold over-the-counter would help curb the
growing number of opioid overdose deaths . The FDA has been reluctant to consider approving OTC versions of injectable naloxone, but it has signaled that it wouldn’t turn down OTC versions of the auto-injectable and nasal spray products. Last month, the FDA even formallyAdvertisement The company announced early Tuesday that the FDA has agreed to conduct a priority review of its application for a 4 milligram OTC version of Narcan—purportedly the first such review for any product switching from prescription to OTC. Priority reviews speed up the typical timeline for the FDA to evaluate a potential approval, usually to
within six months of the application being submitted. According to Emergent, the agency’s deadline to decide on the approval of its“As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country,” said Robert G. Kramer, president and CEO of Emergent, in afrom the company.
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