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FDA Accepts Gadoquatrane New Drug Application

Bayer’s low-dose contrast agent seeks approval for contrast-enhanced MRI of the CNS and other regions for adults and pediatric patients.

By: Rachel Klemovitch

Assistant Editor

Bayer announced that a New Drug Application (NDA) for its investigational contrast agent gadoquatrane has been accepted for review by the U.S. Food and Drug Administration (FDA). The NDA for gadoquatrane has been filed for contrast-enhanced magnetic resonance imaging of the central nervous system (CNS) and other body regions in adults and pediatric patients, including neonates. Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent in clinical development for contras...

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