Bayer's AMBELVIST Receives FDA Approval As Lowest-Dose Macrocyclic Gadolinium-Based Contrast Agent For Contrast-Enhanced MRI In Adult And Pediatric CNS And Non-CNS Applicatio

BAYER AG

BAYER AG

BAYRY

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  • Bayer's AMBELVIST (gadoquatrane) becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight delivering 0.04 mmol Gd/kg body weight1
  • Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight1