The injection is designed to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).
Previously, gadavist was approved for this use in patient populations over the age of two.
Priority review from the FDA was based on a trial showing that the pharmacokinetic (PK) and safety profiles in pediatric patients less than two years of age were similar to that of older children and adults at standard dose of 0.1mmol/kg.
A total of 47 pediatric patients with ages spanning from term neonates to 23 months with normal renal function were enrolled in the trial from nine centers across the US, Canada and Europe.
The company said that 44 pediatric patients were evaluated for safety and efficacy, while 43 were eligible for a PK profile evaluation, including nine term neonates less than two months of age.
University of Alberta study investigator and pediatric radiologist Dr Ravi Bhargava said: "Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than two years of age, and there has been a significant need to better understand how they work in our youngest patients."
Bayer HealthCare Medical Care division chief medical officer and head of Innovation Christiane Pering said: "Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under two years of age, including term neonates, and the approval provides guidance to physicians on how to use Gadavist in these young patients.
"With this label expansion, Gadavist is appropriate to use for MRI of the central nervous system at a standard dose of 0.1mmol/kg for patients of all ages – term neonates to adults."