Reviews of abbreviated new drug applications referencing opioid overdose treatments based on nalmefene or naloxone will now be expedited by the US Food and Drug Administration. Specifically, the agency is looking to accelerate its assessment of ANDAs referencing Adapt Pharma’s Narcan, Kaléo’s Evzio and Baxter’s Revex.
Based on the recent renewal of a crisis declaration originally made in October 2017 by acting US Department of Health and Human Services secretary Eric Hargan, the agency has now invoked the ‘public health emergency’ prioritization factor in its manual of policies and procedures, or MAPP, 5240.3
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