LONDON, RESEARCH TRIANGLE PARK, N.C., and MISSISSAUGA, Ontario, Dec 01, 2010 /PRNewswire via COMTEX/ -- 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 beaddressed 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.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com/
About Valeant - Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics. More information about Valeant can be found at http://www.valeant.com/.