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

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:

• Narcan (naloxone hydrochloride) injection, NDA 016636
• Narcan (naloxone hydrochloride) nasal spray, NDA 208411
• Evzio (naloxone hydrochloride) auto-injector, NDA 205787
• Evzio (naloxone hydrochloride) auto-injector, NDA 209862
• Revex (nalmefene hydrochloride) injection, NDA 020459

These products are opioid antagonists and are critical medications for saving the lives of individuals impacted by the ongoing opioid crisis.

For this reason, FDA will prioritize the review of ANDA submissions that reference any of the aforementioned RLDs, with the goal of improving access to these critical medications. As part of this priority review:

• For any ANDAs that may already have been submitted and that reference these RLDs, starting with the next solicited amendment, any such ANDAs may receive either shorter goal dates or an expedited review, where FDA will act on an ANDA as soon as possible, even though the submission will not result in a shorter goal date. Any such ANDAs may also be eligible for increased assessment communications. For questions about an application under review, contact the Regulatory Project Manager assigned to the application.
• New original ANDAs for these RLDs may be eligible for enhanced communication and support in the form of product development, pre-submission, and mid-review-cycle meetings, and these ANDAs will be prioritized for review and may be eligible to receive either shorter goal dates or standard goal dates with earlier internal reviewer deadlines. These ANDAs may also be eligible for increased assessment communications. For information on product development, pre-submission, and mid-review-cycle meetings, see the October 2017 Draft Guidance for Industry Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.
• If an applicant is not currently marketing an approved ANDA for one of these RLDs 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. For questions about reactivating a discontinued ANDA, contact the Office of Generic Drugs, Office of Regulatory Operations Supplement Team at 240-402-8859.

Related Resources:

• Press Release - FDA approves first generic naloxone nasal spray to treat opioid overdose
• MAPP 5240.3 - Prioritization of the Review of Original ANDAs, Amendments, and Supplements