FDA approves Dotarem (Guerbet SA) for MRI Imaging
The FDA has on 20 March 2013 approved Dotarem (gadoterate meglumine) from Guerbet SA, for use in Magnetic Resonance Imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity.
Commercialized widely throughout the world (including the EU) since 1989, Dotarem has been administered to more than 30 million patients having received an MRI scan.
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