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.
Related Reading
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Gadobenate better than gadopentetate contrast in MRA, May 24, 2010
Bayer settles NSF case with Calif. man, January 28, 2010
Bayer initiates phase III trial, December 1, 2009
Bayer partners with Hamamatsu, January 12, 2009
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