Is Givinostat approved by the US FDA?

Drugs@FDA lists 1 application product line for Givinostat, including DUVYZAT (Prescription).

Is Givinostat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Givinostat: Duvyzat.

Active substance

Givinostat

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
DUVYZAT	EQ 8.86MG BASE/ML	suspension · oral	ITALFARMACO SPA	Prescription	21 Mar 2024

EMA European Union — centrally authorised medicines

Duvyzat Italfarmaco S.p.A. · Authorised · authorised 6 Jun 2025 · ATC M09AX14

Therapeutic indication (EMA)

Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.

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.