As part of nationwide efforts to address the opioid crisis, FDA is taking a closer look at the development of critical medications that combat overdose deaths. Most recently, FDA announced its intention to prioritize review of ANDAs for drug products indicated for emergency use in known or suspected opioid overdose. Applications granted priority review can benefit from shorter review times and enhanced communication with FDA.
Why is FDA prioritizing opioid antagonist ANDAs?
FDA’s action is based on the Department of Health and Human Services’ declaration that the opioid crisis constitutes a Public Health Emergency. In response to this declaration, FDA’s Manual of Policy and Procedure (MAPP) 5240.3 Prioritization of the Review of Original ANDAs, Amendments, and Supplements enables the Office of Generic Drugs to prioritize review of these ANDAs, so long as the emergency exists.
Which ANDAs are eligible for priority review?
Prioritization is extended to ANDA applications that rely on any of the following reference listed drugs (RLDs), which are indicated for the emergency treatment of known or suspected opioid overdose:
- 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
ANDA applications relying on these RLDs will not be without challenges: several of the RLD products have been withdrawn, and several have patent protection extending past 2030.
How will FDA address ANDAs at different stages in the review process?
The FDA announcement outlines the planned approach for ANDAs at various stages in the review process:
|ANDA Status||Approach||Resources for More Information|
|Already submitted ANDAs||Starting with the next solicited amendment, 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.
Applicants may 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||ANDAs will receive prioritized review and may be eligible to receive either shorter goal dates or standard goal dates with earlier internal reviewer deadlines.
Applicants may be eligible for enhanced communication and support in the form of product development, pre-submission, and mid-review-cycle meetings.
|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 .|
|Approved ANDAs not currently marketed||Applicants are invited to seek FDA guidance on what is needed before a supplement is submitted to return the application to active status.||For questions about reactivating a discontinued ANDA, contact the Office of Generic Drugs, Office of Regulatory Operations Supplement Team at 240-402-8859.|
This FDA initiative may present a significant opportunity for those considering entering the generic market for these opioid overdose products. Contact us to learn more about our deep knowledge and experience in developing opioid antagonists and abuse-deterrent opioids.
For more Premier Consulting coverage on FDA initiatives to address the ongoing opioid crisis and how these efforts could impact your development program, explore these posts: