Is Vadadustat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Vadadustat, including VAFSEO (Prescription); VAFSEO (Discontinued).

Is Vadadustat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vadadustat: Vafseo.

Are there safety signals or safety updates for Vadadustat?

US FDA: 1 entry (latest 2026-04-01).

Active substance

Vadadustat

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
VAFSEO	150MG; 300MG	tablet · oral	AKEBIA	Prescription	27 Mar 2024
VAFSEO	450MG	tablet · oral	AKEBIA	Discontinued	27 Mar 2024

EMA European Union — centrally authorised medicines

Vafseo Medice Arzneimittel Pütter GmbH & Co. KG · Authorised · authorised 24 Apr 2023

Therapeutic indication (EMA)

Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Safety signals and safety-related labeling changes

US FDA 1 Apr 2026 VAFSEO — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for vadadustat →

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.