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FDA approves Bayer contrast agent
The US FDA has approved Bayer HealthCare's Gadavist (gadobutrol for use in patients aged two and over undergoing MRI scanning of the central nervous system
The US Food and Drug Administration (FDA) has approved Bayer HealthCare's Gadavist (gadobutrol), a highly concentrated gadolinium-based contrast agent for use in patients aged two and over undergoing magnetic resonance imaging (MRI) of the central nervous system.
The product, which is the sixth gadolinium-based contrast agent (GBCA) to be approved in the US for use in MRI of the central nervous system, is more concentrated than the other approved products and is administered at half the volume with a more compact contrast bolus.
In clinical studies, the drug improved the visualisation of lesions in the central nervous system when compared to MRI scans without contrast.
Like all GBCAs, Gadavist will carry a boxed warning about the risk of nephrogenic systemic fibrosis (NSF), a rare but serious condition associated with the use of GBCAs in some patients with kidney dysfunction. However, Gadavist appears to be one of the GBCAs with a lower risk of NSF and is not contraindicated in patients with acute kidney injury or chronic, severe kidney disease, according to the FDA.
"The approval of Gadavist enriches our strong portfolio of MRI contrast media and provides a new option for US healthcare providers in contrast-enhanced imaging of the CNS," said John Rotondo, VP commercial operations, Bayer HealthCare Pharmaceuticals.
The FDA made its decision after reviewing a marketing application that included two clinical studies involving 657 patients.
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