FDA accepts Bayer's NDA for MR contrast agent, Gadovist

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The FDA has accepted Bayer Schering Pharma's new drug application (NDA) for its gadolinium-based contrast agent for MR imaging, gadobutrol injection (Gadovist 1.0).

The macrocyclic, non-ionic gadolinium-based contrast agent has been supported by two Phase III studies--the first of which compared the efficacy of combined gadobutrol-enhanced images plus unenhanced images to unenhanced images alone, and the second of which confirmed noninferiority of combined gadobutrol imaging versus combined gadoteridol imaging, said the Berlin-based company.