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Complete response for Valeant's ezogabine

December 2, 2010 1:27 AM UTC

FDA issued a complete response letter to Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX) for an NDA for ezogabine as an adjunctive treatment for partial-onset seizures. According to Valeant and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), FDA cited non-clinical reasons for the letter. The partners plan to respond as soon as possible in 2011. ...