Is Sunitinib malate approved by the US FDA?

Drugs@FDA lists 10 application product lines for Sunitinib malate, including SUTENT (Prescription); SUTENT (Prescription); SUNITINIB MALATE (Prescription); SUNITINIB MALATE (Prescription); SUNITINIB MALATE (Prescription).

Are there safety signals or safety updates for Sunitinib malate?

US FDA: 1 entry (latest 2021-08-30).

Active substance

Sunitinib malate

US FDA 10
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
SUTENT	EQ 12.5MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 37.5MG BASE	capsule · oral	CPPI CV	Prescription	26 Jan 2006
SUTENT	EQ 12.5MG BASE; EQ 25MG BASE; EQ 50MG BASE	capsule · oral	CPPI CV	Prescription	26 Jan 2006
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	SUN PHARM	Prescription	16 Aug 2021
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	TEVA PHARMS USA	Prescription	30 Nov 2021
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	MYLAN	Prescription	6 Dec 2021
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	DR REDDYS	Prescription	11 Apr 2022
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	FOSUN WANBANG	Prescription	21 Aug 2023
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	NATCO PHARMA	Prescription	24 Oct 2023
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	EUGIA PHARMA	Prescription	14 Mar 2024
SUNITINIB MALATE	EQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASE; EQ 50MG BASE	capsule · oral	MSN	Prescription	14 Feb 2025

Safety signals and safety-related labeling changes

US FDA 30 Aug 2021 SUTENT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sunitinib malate →

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.