Is Tivozanib approved by the US FDA?

Drugs@FDA lists 1 application product line for Tivozanib, including FOTIVDA (Prescription).

Is Tivozanib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tivozanib: Fotivda.

Are there safety signals or safety updates for Tivozanib?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2024-08-06).

Active substance

Tivozanib

US FDA 1
EMA 1
Safety 4

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
FOTIVDA	EQ 0.89MG BASE; EQ 1.34MG BASE	capsule · oral	AVEO PHARMS	Prescription	10 Mar 2021

EMA European Union — centrally authorised medicines

Fotivda Recordati Netherlands B.V. · Authorised · authorised 24 Aug 2017 · ATC L01EK03

Therapeutic indication (EMA)

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. Treatment of advanced renal cell carcinoma.

Safety signals and safety-related labeling changes

US FDA 6 Aug 2024 FOTIVDA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jul 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No

All safety entries for tivozanib →

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.