Berlin, July 8, 2008 –The U.S. Food and Drug Administration (FDA) has approved Bayer Schering Pharma’s magnetic resonance imaging (MRI) contrast agent Primovist® (gadoxetate disodium) for the detection and characterization of liver lesions in adults with known or suspected focal liver disease. The product will be marketed in the United States under the name EOVIST®; it is currently marketed as Primovist outside the U.S. and as EOB Primovist in Japan. It is the first organ-specific MRI contrast agent to be approved in the U.S. for over a decade. Bayer plans to make EOVIST available to customers in the U.S. in the summer of 2008.
“Primovist not only offers the unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions, but also helps to guide and follow-up on treatment decisions, as it enables radiologists to identify even tiny pathological liver lesions,” said Dr. Gunnar Riemann, Member of the Board of Management of Bayer Schering Pharma AG, responsible for the company’s Business Units. “Bayer is now in the unique position of offering Primovist for diagnosing patients with liver cancer and Nexavar for treating hepatocellular carcinoma – the most common form of liver cancer.”
- Doreen Schröder
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