Bayer seeks USFDA nod for Gadoquatrane for contrast enhanced magnetic resonance imaging of CNS
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-06-17 07:14 GMT | Update On 2025-06-17 07:14 GMT
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Berlin: Bayer has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates.
The submitted dose is 0.04 mmol gadolinium per kilogram body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., corresponding to a 60 percent reduction compared to standard of care macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
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