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FDA to Speed Review of Generic Versions of Opioid Overdose Antidote

By Zachary Brennan, Regulatory Affairs Professionals Society, on 7/8/2019 

The US Food and Drug Administration (FDA) on Monday said it would prioritize and expedite the review of generic versions of drugs indicated for the emergency treatment of opioid overdoses.

The decision follows FDA’s approval in April of the first generic of the life-saving naloxone nasal spray, commonly known as Narcan.

Under the “Public Health Emergency” prioritization factor in MAPP 5240.3, FDA says it will expedite the review of all abbreviated new drug applications (ANDAs) that reference new drug applications (NDAs) for drugs indicated for the emergency treatment of known or suspected opioid overdose. The NDAs include the Narcan injection and nasal spray, Evzio auto-injector and Revex injection.

As part of this priority review, already-submitted ANDAs may receive either shorter goal dates or an expedited review, in addition to the possibility of increased communications with the agency, FDA says.
 
New original naloxone ANDAs will be prioritized and may be eligible for enhanced communication too, to support product development, pre-submission and mid-review-cycle meetings, FDA adds. They also may be eligible to receive either shorter goal dates or standard goal dates with earlier internal FDA reviewer deadlines.
 
“If an applicant is not currently marketing an approved ANDA for one of these RLDs [reference listed drugs] and the applicant is interested in resuming marketing of the drug product(s), the Office of Generic Drugs invites the applicant to call the Office of Generic Drugs before they submit a supplement to return the application to active status. FDA will work with such applicants to provide guidance on what is needed,” the agency says.

FDA Announcement