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Fenfluramine was originally developed as an appetite suppressant and sold under the brand name Pondimin until it was withdrawn from the U.S. market in 1997.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
|Jun 25, 2020|| FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome|
|Feb 27, 2020||Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome|
|Feb 6, 2020||Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of Fintepla for the Treatment of Lennox-Gastaut Syndrome|
|Dec 17, 2019||The Lancet Publishes Phase 3 Trial Results for Zogenix Investigational Drug Fintepla in Dravet Syndrome|
|Dec 2, 2019||JAMA Neurology Publishes Phase 3 Study of Zogenix Investigational Drug Fintepla in Dravet Syndrome Patients Taking Stiripentol-Containing Antiepileptic Drug Regimens|
|Nov 25, 2019||Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome|
|Sep 26, 2019||Zogenix Resubmits New Drug Application for Fintepla for the Treatment of Dravet Syndrome to U.S. Food and Drug Administration|
|Jun 27, 2019||Zogenix Announces FDA Agreement to Proceed with Resubmission of Fintepla NDA|
|Apr 8, 2019||Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application|
|Feb 6, 2019||Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome|
|Dec 3, 2018||Zogenix Announces Positive Phase 3 Trial Results on the Efficacy and Safety of Fintepla (ZX008) in Dravet Syndrome|
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