USA – FDA announces public health emergency prioritization of ANDAs for drug products for the emergency treatment of opioid overdose

In accordance with the Center for Drug Evaluation and Research’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original Abbreviated New Drug Applications (ANDAs), Amendments, and Supplements, ANDA submissions for drug products indicated for the emergency treatment of known or suspected opioid overdose are eligible for priority review.
Based on the Secretary of the U.S. Department of Health and Human Services’ public health emergency declaration related to the opioid crisis, the Agency has invoked the “Public Health Emergency” prioritization factor in MAPP 5240.3 to expedite the review of all ANDAs that reference new drug applications (NDAs) for drugs indicated for the emergency treatment of known or suspected opioid overdose. FDA will continue to prioritize the review of these products while the public health emergency exists. 
The NDA reference listed drugs (RLDs) in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) that are indicated for the emergency treatment of known or suspected opioid overdose are NDAs…