Is Allopurinol + Lesinurad approved by the US FDA?

Drugs@FDA lists 1 application product line for Allopurinol + Lesinurad, including DUZALLO (Discontinued).

Is Allopurinol + Lesinurad authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Allopurinol + Lesinurad.

Active substances

Allopurinol + Lesinurad

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
DUZALLO	200MG;200MG; 300MG;200MG	tablet · oral	IRONWOOD PHARMS INC	Discontinued	18 Aug 2017

EMA European Union — centrally authorised medicines

Duzallo Grunenthal GmbH · Withdrawn · authorised 23 Aug 2018 · ATC M04AA51

Therapeutic indication (EMA)

Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.

Components

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.