Bracco lands new FDA approval for MultiHance

Contrast developer Bracco Diagnostics has received U.S. Food and Drug Administration (FDA) approval for the use of its MultiHance contrast agent for MRI of the central nervous system (CNS) in pediatric patients younger than 2 years, including neonates.

The labeling of MultiHance has now been extended to visualize lesions in these patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues, according to Bracco. Data obtained specifically in patients younger than 2 years old showed that a dose of 0.1 mmol/kg significantly improves the visualization and morphologic assessment of CNS lesions, the company said. However, a dose of 0.05 mmol/kg was shown to be effective at improving the visualization of brain and spine lesions in neonates and infants.

This provides healthcare professionals with dosing flexibility depending on the patient, imaging conditions, and need, Bracco said.

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