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FDA panel backs Potiga

August 11, 2010 11:39 PM UTC

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-0 that Valeant Pharmaceuticals International (NYSE:VRX) has demonstrated substantial evidence of the effectiveness of Potiga ezogabine as an adjunctive therapy for partial-onset seizures. On a pair of safety questions, the panel voted 11-0, with two abstentions, that Potiga's observed risk of urinary retention can be mitigated by patient monitoring, and 13-0 that monitoring for infection and urolithiasis should not be required. ...