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- Fenfluramine was originally developed as an appetite suppressant and sold under the brand name Pondimin until it was withdrawn from the U.S. market in 1997.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