REMS Submission Delays Decision on GSK, Valeant Epilepsy Drug

The FDA has pushed back the user fee action goal date for GlaxoSmithKline (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). Although the original decision date was Aug. 30, GSK submitted a REMS Aug. 26 in response to an FDA request 10 days earlier, the company said.
Washington Drug Letter