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FDA posts Potiga briefing documents

August 10, 2010 12:40 AM UTC

FDA said Potiga ezogabine from Valeant Pharmaceuticals International (NYSE:VRX) is an effective adjunctive therapy for partial-onset seizures in briefing documents posted ahead of Wednesday's Peripheral and Central Nervous System Drugs Advisory Committee to discuss an NDA for Potiga. The agency did identify potential urological safety issues, including voiding dysfunction and urinary retention, which in most cases was shown to be reversible. The documents noted that the urological safety issues could be adequately managed by Valeant's proposed labeling and medication guide. Valeant also has proposed to conduct a prospective epidemiologic study to further assess the risk of urinary retention. ...