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Posted 7 Jan 2015 by Drugs.com
LEVERKUSEN, Germany, Jan. 5, 2015 /PRNewswire/ – Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.1 Gadavist was previously approved for this use in patient populations over the age of 2. The FDA's priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients less than 2 years of age were similar to that of older children and adults at standard dose (0.1 mmol/kg).1 "Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and ... Read more