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FDA Prioritizes Reviews Of Opioid Overdose ANDAs

 
• By Aidan Fry

Opioid overdose treatments containing naloxone or nalmefene are now eligible for expedited ANDA review in a bid by the FDA to improve patient access.

May 26, 2017-ogden Utah USA: naloxone and narcan nasal sprays are now available over the counter to prevent drug overdoses. - Illustration
Narcan is among the reference brands for which the FDA is accelerating ANDA review • Source: Shutterstock

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Based on the recent renewal of a crisis declaration originally made in October 2017 by acting US Department of Health and Human Services secretary Eric Hargan, the agency has now invoked the ‘public health emergency’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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