FDA extends indication of MultiHance to include imaging of pediatric patients.

Approval was granted for an extension to include MRI of the CNS in pediatric patients younger than 2 years of age (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues.

The approval was based on data specifically obtained in pediatric patients younger than 2 years of age. Similar to older pediatric patients and adults, a dose of 0.1 mmol/kg was shown to significantly improve the visualization and morphologic assessment of CNS lesions. In neonates and infants, however, a dose of 0.05 mmol/kg is effective at improving the visualization of lesions in the brain and the spine. This provides health care professionals with dosing flexibility depending on patient and imaging conditions and needs.