FDA Week - 07/12/2019

FDA Invokes Priority Review For Generic Overdose Reversal Drugs

By Beth Wang
July 8, 2019 at 5:11 PM
FDA is expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection, the agency announced Monday (July 8). FDA initially indicated back in April that it would grant priority review to all abbreviated new drug applications (ANDAs) for products indicated for emergency treatment of opioid overdose, but Monday’s announcement lays out the details and names the brand drugs that can be referenced in ANDAs. On Monday, FDA announced it has...

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