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Guerbet SA Announces that Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem


Monday, 18 Feb 2013 11:56am EST 

Guerbet SA announced that the Medical Imaging Drugs Advisory Committee to United States Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age. 

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