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FDA Approves EOVIST(R) to Detect and Characterize Focal Liver Lesions
Date:7/8/2008

First Organ-specific MRI Contrast Agent Approved in the United States in

More Than a Decade

WAYNE, N.J., July 8 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved EOVIST(R) (Gadoxetate Disodium) Injection, a gadolinium-based contrast agent, for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. The approval makes EOVIST the first organ-specific MRI contrast agent approved in the United States in more than a decade.

"The approval of EOVIST in the United States marks a significant achievement in advancing the accurate diagnosis of liver disease," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals. "This milestone demonstrates Bayer HealthCare Pharmaceuticals' commitment to providing innovative imaging products that can help improve the lives of patients."

EOVIST is a paramagnetic MRI contrast agent that combines features of both an extracellular contrast agent and a hepatocyte-specific agent. EOVIST is administered via an intravenous, bolus injection and has a dual route of excretion with approximately 50 percent eliminated through the liver and 50 percent eliminated through the kidney. Detection and characterization of malignant and benign focal liver lesions with EOVIST may help enhance diagnostic accuracy and increase diagnostic confidence.

"EOVIST-enhanced images can provide more comprehensive information about focal liver lesions in a single, short imaging session than was previously available," said Jeffrey Brown, MD, Professor of Radiology, Washington University School of Medicine, St. Louis. "With the availability of EOVIST, our ability to evaluate patients with benign and malignant focal hepatic lesions will
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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