FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries

29 April 2016 - Bayer announced today that the U.S. FDA has approved Gadavist (gadobutrol) injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates).

The FDA approval is based on the results of two, multi-center, Phase 3, open-label clinical studies – the GEMSAV study of patients with known, or suspected vascular disease, of the supra-aortic arteries and the GRAMS study of patients with known or suspected renal artery disease.

For more details, go to: https://www.bayer.us/en/article.php?id=122984

Michael Wonder

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Michael Wonder

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Outcome , US , Diagnostic agent