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Gadavist Approval History

  • FDA approved: Yes (First approved March 14th, 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 History and FDA Approval Process for Gadavist

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

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