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# Zogenix Given ‘Refusal to File” on Fintepla NDA
- URL: https://www.fdaweb.com/zogenix-given-refusal-to-file-on-fintepla-nda/
- Published: 2019-04-09T12:00:00.000Z
- Updated: 2026-09-15T01:19:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143819

FDA has issued Zogenix a “refusal to file” letter for its for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome. “Upon its preliminary review, the FDA determined that the NDA, submitted on 2/5/2019, was not sufficiently complete to permit a substantive review,” the company says. In the letter, it says, the agency cited two reasons for its refusal: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the NDA. FDA has not requested or recommended additional clinical efficacy or safety studies, Zogenix says, adding that a meeting will be requested to receive further clarification.