ARTICLE | Clinical News

Potiga ezogabine regulatory update

August 16, 2010 7:00 AM UTC

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-0 that Valeant 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. ...