DOTAREM

FDA-2017-P-4249

GE Healthcare Inc filed a citizen petition requesting that the FDA update the Orange Book product listing for Dotarem (gadoterate meglumine) to reflect suitability for pediatric magnetic resonance imaging applications, based on new clinical data demonstrating safety and efficacy in the pediatric pop

FDA-2017-P-4249

GE Healthcare Inc. filed this suitability petition under section 505(j)(2)(c) requesting FDA approval to add a 5mL vial size for its proposed generic drug product Clariscan (gadoterate meglumine) Injection, a gadolinium-based contrast agent for intravenous use in magnetic resonance imaging, to addre

FDA-2017-P-4249

GE Healthcare Inc filed this citizen petition requesting FDA action regarding the approved labeling for Dotarem, a gadolinium-based contrast agent. The petition seeks modifications to the product's approved label to reflect updated safety and suitability information for clinical use.