ARTICLE | Company News

FDA extends ezogabine review

September 1, 2010 12:36 AM UTC

Valeant Pharmaceuticals International (NYSE:VRX) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA extended the PDUFA date for an NDA for ezogabine to Nov. 30 from Aug. 30. The partners attributed the delay to Valeant's submission of a formal REMS for ezogabine at the agency's request. ...