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Fintepla Approval Status

FDA Approved: No
Brand name: Fintepla
Generic name: fenfluramine
Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla (ZX008, low-dose fenfluramine) is an amphetamine derivative in development for the treatment of seizures associated with Dravet syndrome.

Fenfluramine was originally developed as an appetite suppressant and sold under the brand name Pondimin until it was withdrawn from the U.S. market in 1997.

Development Status and FDA Approval Process for Fintepla

Sep 26, 2019Zogenix Resubmits New Drug Application for Fintepla for the Treatment of Dravet Syndrome to U.S. Food and Drug Administration
Jun 27, 2019Zogenix Announces FDA Agreement to Proceed with Resubmission of Fintepla NDA
Apr  8, 2019Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application
Feb  6, 2019Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome
Dec  3, 2018Zogenix Announces Positive Phase 3 Trial Results on the Efficacy and Safety of Fintepla (ZX008) in Dravet Syndrome
Sep 29, 2017Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome
Jun  7, 2016Zogenix Announces Initiation of Multi-National Phase 3 Clinical Trial for ZX008 in Dravet Syndrome

Further information

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