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