Gadavist Injection Gains Expanded Age Range
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.