Bayer HealthCare Pharmaceuticals' new drug application (NDA) for a new gadolinium-based MRI contrast agent has been accepted for review by the U.S. Food and Drug Administration (FDA).
The Wayne, NJ-based company's Gadovist 1.0 (gadobutrol injection) gadolinium-based contrast agent has completed two phase III studies.
The first phase III study compared the efficacy of combined gadobutrol-enhanced images plus unenhanced images to unenhanced images alone.
The second phase III study used an active control, gadoteridol, to compare the efficacy of the combined gadobutrol-enhanced and unenhanced images to unenhanced images alone, as well as to confirm the quality of combined gadobutrol imaging versus combined gadoteridol imaging.
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