Yesterday, FDA announced the eligibility of ANDAs submitted for drug products indicated for the emergency treatment of known or suspected opioid overdose, to be granted priority review status (either shorter goal dates, or expedited review without formal reduction of the goal date) under the public health emergency option stated in MAPP 5240.3 (priority criterion number 4). This announcement was based on the Secretary of the US Department of Health and Human Services declaration of April 15, 2019 which renewed the prior determination that a public health emergency exists as a result of the opioid crisis. Five opioid antagonist Reference Listed Drugs (RLDs) were specified in FDA’s announcement, as follows:
- 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
While the public health emergency exists, firms that have submitted ANDAs which rely on these RLDs as their basis for submission may request that FDA prioritize their review. MAPP 5240.3 notes that priority criteria apply at all stages of review, and that a determination regarding priority review may be made at the time that the original ANDA is received or during review of the ANDA. FDA noted yesterday that ANDAs already submitted for these products may receive a shorter goal date, starting with the next solicited amendment, or an expedited review (where there is no goal date change, but FDA will act as quickly as possible) and may be eligible for increased assessment communications. ANDAs not yet submitted (new original ANDAs) may be eligible for enhanced communication and support in the form of meetings, as described under FDA’s October 2017 Draft Complex Product Meetings Guidance and will be prioritized (meaning they may either be eligible for shorter goal dates, or otherwise be expedited via setting shorter internal FDA reviewer deadlines, within the established standard goal dates). FDA has also offered to work directly with any firms that are considering reactivation of any approved ANDAs for these products that are not currently marketed, by providing input on the required content in advance of supplement submission. Firms seeking to have FDA grant priority review status for their submitted opioid antagonist ANDA drug products are encouraged to contact their Regulatory Project Manager and to contact the Office of Generic Drugs, Office of Regulatory Operations Supplement Team via telephone at 240-402-8859 with any questions about reactivating a discontinued ANDA.
If you have any questions about navigating this complex landscape, we can certainly guide you through. Please contact us Amy Schutte (A.Schutte@LachmanConsultants.com) or Aloka Srinivasan (A.Srinivasan@LachmanConsultants.com).