Dotarem Approval History
- FDA approved: Yes (First approved March 20th, 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
|Mar 20, 2013||FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent|
|Feb 15, 2013||Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem (gadoterate meglumine)|
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