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First Adult Injection in US of Dotarem® (gadoterate meglumine) Performed at Winthrop-University Hospital in New York
Date:9/5/2013

of Radiology, Winthrop-University Hospital and Clinical Professor of Radiology, State University of New York at Stony Brook. “This conservative decision not to use contrast could lead to some delays in certain aspects of a patient’s care. The introduction of Dotarem, in our view, gives us a new option for these cases.”
Dotarem was approved by the FDA in March 2013 and began shipping to radiology departments in July.

“We are extremely pleased that Winthrop University Hospital, a major teaching facility in the US, is the first hospital to use Dotarem in an adult patient to enhance an MRI procedure,” said Massimo Carrara, General Manager, Guerbet US.

Dotarem® - which has been commercialized widely throughout the world since 1989 with more than 37 million doses administered[1] - is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight (BW). Dotarem® Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and pre filled syringes.
MRI has become the mainstay of central nervous system imaging since its introduction over 20 years ago. It is estimated that there were more than 10 million contrast-enhanced MRI examinations performed in the US in 2011, with approximately 60 percent of these examinations performed to image the CNS.

Clinical Studies

The Dotarem® New Drug Application included two Phase III clinical studies. These studies evaluated the diagnostic efficacy and safety of Dotarem® for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Both phase III studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization in all three co
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