The FDAs Peripheral and Central Nervous System Drugs Advisory Committee has voted unanimously that clinical trial and post-marketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (Gadovist, Bayer HealthCare Pharmaceuticals), support approval of the product for proposed use in diagnostic MRI in adults and children (two years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.