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# Zogenix Review Extension for Dravet Syndrome Drug
- URL: https://www.fdaweb.com/zogenix-review-extension-for-dravet-syndrome-drug/
- Published: 2020-02-27T12:00:00.000Z
- Updated: 2026-09-14T16:04:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146196

FDA has extended by three months its review of a Zogenix NDA for Fintepla (fenfluramine oral solution) for treating seizures associated with Dravet syndrome. The new user fee review action target date is 6/25.

The extension allows the agency time to review additional data submitted by Zogenix in response to a recent information request, the company says. FDA determined that the information submission constituted a major amendment to the NDA, necessitating the review extension.

The NDA was originally accepted 11/2019 and included data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.