Bayer HealthCare Pharmaceuticals Inc. announced today
that the FDA has approved GadavistT (gadobutrol) Injection, a macrocyclic
gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic
magnetic resonance imaging (MRI) in adults and children (2 years of age and
older) to detect and visualize areas with disrupted blood brain barrier (BBB)
and/or abnormal vascularity of the central nervous system (CNS).
Gadavist is formulated at a higher concentration (1 mmol/mL)
compared to certain other GBCAs. Compared to 0.5 molar gadolinium-based contrast
agents, the higher concentration of Gadavist results in half the volume of
administration and a more compact contrast bolus. It is important to closely
examine the dosing table in the full prescribing information to determine the
volume of Gadavist to be administered.
“The approval of Gadavist enriches our strong portfolio
of MRI contrast media and provides a new option for U.S. healthcare providers in
contrast-enhanced imaging of the CNS,” said John Rotondo, Vice President,
Commercial Operations, Bayer HealthCare Pharmaceuticals.
“Our MR contrast agents are some of the most widely
used today, and Bayer is proud to be a world leader in diagnostic imaging.”