The US Food and Drug Administration (FDA) recently granted final approval of the first generic naloxone hydrochloride nasal spray, a medication that can stop or reverse the effects of an opioid overdose. The FDA is taking measures to address the opioid crisis, by prioritizing review of generic drug applications implicated for treating opioid overdose. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines and enhanced communication. The recent generic naloxone nasal spray approval is the first for use in a community setting by individuals without medical training, as a result of a push by the agency to increase availability of naloxone products intended for use in the community. The FDA is addressing the public health emergency by further expanding availability and access to overdose reversal drugs.
>> FDA Press Release
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