Medication Monitor

Generic Name (Trade Name—Company)
July 17, 2019


Gadobutrol becomes first FDA-approved contrast agent for use in cardiac MRI

FDA has approved gadobutrol injection, the first contrast agent for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

Gadobutrol-enhanced cardiac MRI demonstrated efficacy in a large, global, multicenter Phase III clinical trial of almost 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy.

Cardiac MRI is now the fourth FDA-approved indication for Gadobutrol, which was originally approved in 2011.