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Gadavist FDA Approval History

FDA Approved: Yes (First approved March 14, 2011)
Brand name: Gadavist
Generic name: gadobutrol
Dosage form: Injection
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnosis and Investigation

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).

Development timeline for Gadavist

Jul 15, 2019Approval FDA Approves Gadavist (gadobutrol) Contrast Agent for Use in Cardiac MR in Adult Patients with Known or Suspected Coronary Artery Disease
Apr 29, 2016Approval FDA Approves Bayer's Gadavist (gadobutrol) Injection for use with Magnetic Resonance Angiography of Supra-Aortic Arteries
Jan  5, 2015Approval FDA Approves Gadavist (gadobutrol) as the First MRI Contrast Agent for Patients Less Than 2 Years
Mar 15, 2011Approval U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System

Further information

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