Fintepla FDA Approval History
Last updated by Judith Stewart, BPharm on July 6, 2022.
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, Lennox-Gastaut Syndrome
Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut 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- Fenfluramine was originally developed as an appetite suppressant and sold under the brand name Pondimin until it was withdrawn from the U.S. market in 1997.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
|Mar 28, 2022||Approval Fintepla (fenfluramine) Oral Solution Now FDA Approved for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS)|
|Jun 25, 2020||Approval 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|
|Sep 29, 2017||Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome|
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