Gadoxetate Disodium

FDA Drug Profile — EOVIST

Drug Details

Generic Name
Gadoxetate Disodium
Brand Names
EOVIST
Application Number
NDA022090
Sponsor
Bayer HealthCare Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
GADOXETATE DISODIUM

Indications and Usage

1 INDICATIONS AND USAGE EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. ( 1 )