Bayer said it has received approval from the U.S. Food and Drug Administration (FDA) for the use of its Gadavist (gadobutrol) gadolinium-based contrast agent in cardiac MRI applications.
The FDA approval allows for gadobutrol injection during cardiac MRI exams to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected coronary artery disease, according to Bayer. The decision follows reports of the efficacy of gadobutrol for cardiac MR from two phase III clinical trials.
