Dotarem Approved; Contrast Agent for MRIs in Brain, Spine

Guerbet announced that the FDA has approved Dotarem (gadoterate meglumine) injection, a gadolinium-based contrast agent (GBCA), for intravenous use with magnetic resonance imaging in the brain, spine, and associated tissues. Dotarem is a macrocyclic and ionic GBCA indicated in patients >2 years to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity.

The safety and efficacy of Dotarem was evaluated in two Phase 3 clinical studies (n=514).  Both studies evaluated the superiority of the enhanced images over the unenhanced images for CNS lesion visualization in all three co-primary endpoints: contrast enhancement, border delineation, and internal morphology.  All defined primary and key secondary efficacy analyses were met.

Dotarem injection 0.5mmol/mL contains 376.9mg/mL of gadoterate meglumine. It is available in 10mL and 20mL (containing 15mL or 20mL solution) vials and prefilled syringes.

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