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Home » REMS Submission Delays Decision on GSK, Valeant Epilepsy Drug
REMS Submission Delays Decision on GSK, Valeant Epilepsy Drug
September 3, 2010
The FDA has pushed back the user fee action goal date for GlaxoSmithKline’s (GSK) and Valeant Pharmaceuticals’ epilepsy drug ezogabine to Nov. 30, giving the agency more time to review a recently submitted risk evaluation and mitigation strategy (REMS).