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Dotarem Approval History

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

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

Development History and FDA Approval Process for Dotarem

DateArticle
Sep  5, 2017Approval FDA Approves Guerbet's Dotarem (gadoterate meglumine) for Pediatric Patients Younger Than Two Years
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)

Further information

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