Is Fenfluramine approved by the US FDA?

Drugs@FDA lists 2 application product lines for Fenfluramine, including FINTEPLA (Prescription); FENFLURAMINE (Prescription).

Is Fenfluramine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fenfluramine: Fintepla.

Are there safety signals or safety updates for Fenfluramine?

US FDA: 1 entry (latest 2025-10-15).

Active substance

Fenfluramine

US FDA 2
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
FINTEPLA	EQ 2.2MG BASE/ML	solution · oral	UCB INC	Prescription	25 Jun 2020
FENFLURAMINE	2.2MG/ML	solution · oral	APOTEX INC	Prescription

EMA European Union — centrally authorised medicines

Fintepla UCB Pharma S.A. · Authorised · authorised 18 Dec 2020 · ATC N03

Therapeutic indication (EMA)

Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Safety signals and safety-related labeling changes

US FDA 15 Oct 2025 FINTEPLA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fenfluramine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.