Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients <2 years old, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).
Gadavist injection was initially approved in March 2011 for use in patients ≥2 years old. In June 2014, Gadavist was approved to assess the presence and extent of malignant breast disease. Gadavist is now the first approved gadolinium-based contrast agent for pediatric patients <2 years old, including term neonates.
The FDA’s expanded approval was based on a study (n=47) demonstrating that the pharmacokinetic and safety profiles in patients <2 years old were similar to that of older children and adults at the standard dose of 0.1mmol/kg. The adverse event profile was consistent with what was seen in older populations.
For more information call (888) 842-2937 or visit Gadavist.