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