GSK and Valeant receive FDA Complete Response letter for ezogabine

Dec 2 2010

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE: VRX; TSX) announced receipt of a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.  GSK and Valeant are evaluating the Complete Response letter in which FDA cited non-clinical reasons for this action. GSK and Valeant believe that these items can be addressed and the two companies are working for a timely response to the FDA as soon as possible in 2011.

The NDA was submitted to the FDA on 30 October 2009.