Is Lesinurad approved by the US FDA?

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

Is Lesinurad authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Lesinurad.

Active substance

Lesinurad

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
ZURAMPIC	200MG	tablet · oral	IRONWOOD PHARMS INC	Discontinued	22 Dec 2015

EMA European Union — centrally authorised medicines

Zurampic Grünenthal GmbH · Withdrawn · authorised 18 Feb 2016 · ATC M04AB05

Therapeutic indication (EMA)

Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.

Combinations containing Lesinurad

Allopurinol + lesinurad

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.