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FDA accepts retigabine NDA

December 31, 2009 12:17 AM UTC

FDA accepted for review an NDA from Valeant Pharmaceuticals International (NYSE:VRX) for retigabine as an adjunctive therapy for partial-onset seizures in adults with epilepsy. The PDUFA date for the application, which was submitted in October, was not disclosed. Valeant also said that in November EMEA accepted for review an MAA for retigabine in the indication. The potassium channel opener and potentiator of GABA is partnered with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). ...