Monday, January 24, 2011
FDA Advisory Committee Recommends Approval of Bayer's Gadobutrol Injection for MRI of the Central Nervous System
WAYNE, N.J., Jan. 21, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product
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