Is Istradefylline approved by the US FDA?

Drugs@FDA lists 1 application product line for Istradefylline, including NOURIANZ (Prescription).

Is Istradefylline authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Istradefylline.

Active substance

Istradefylline

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
NOURIANZ	20MG; 40MG	tablet · oral	KYOWA KIRIN	Prescription	27 Aug 2019

EMA European Union — centrally authorised medicines

Nouryant Kyowa Kirin Holdings B.V. · Refused · ATC N04

Therapeutic indication (EMA)

Istradefylline is indicated in adults as an adjunctive treatment to levodopa based regimens in patients with Parkinson’s disease (PD) experiencing “OFF” time.

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.