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Fintepla FDA Approval History

FDA Approved: Yes (First approved June 25, 2020)
Brand name: Fintepla
Generic name: fenfluramine
Dosage form: Oral Solution
Company: Zogenix, Inc.
Treatment for: Dravet Syndrome

Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

Fenfluramine was originally developed as an appetite suppressant and sold under the brand name Pondimin until it was withdrawn from the U.S. market in 1997.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

DateArticle
Jun 25, 2020Approval FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
Feb 27, 2020Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome
Feb  6, 2020Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of Fintepla for the Treatment of Lennox-Gastaut Syndrome
Dec 17, 2019The Lancet Publishes Phase 3 Trial Results for Zogenix Investigational Drug Fintepla in Dravet Syndrome
Dec  2, 2019JAMA Neurology Publishes Phase 3 Study of Zogenix Investigational Drug Fintepla in Dravet Syndrome Patients Taking Stiripentol-Containing Antiepileptic Drug Regimens
Nov 25, 2019Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome
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

Further information

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