Dotarem Approval History

  • FDA approved: Yes (First approved March 20th, 2013)
  • Brand name: Dotarem
  • Generic name: gadoterate meglumine
  • Company: Guerbet
  • Treatment for: Diagnosis and Investigation

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

FDA Approval History for Dotarem

DateArticle
Mar 20, 2013Approval FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent
Feb 15, 2013Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem (gadoterate meglumine)

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