FDA clears Bayer's Eovist MRI agent

Bayer HealthCare Pharmaceuticals of Wayne, NJ, has received clearance from the U.S. Food and Drug Administration (FDA) for its gadolinium-based contrast agent, Eovist (gadoxetate disodium).

Eovist is approved for intravenous use in T1-weighted MRI of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

Eovist is marketed by Bayer HealthCare affiliates outside the U.S. as Primovist and in Japan as EOB Primovist. It was first approved in 2004 in Europe. With this FDA decision, Eovist now is approved in more than 40 countries.

The paramagnetic MRI contrast agent combines features of 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% eliminated through the liver and 50% eliminated through the kidney.

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