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Regulatory update – GSK and Valeant respond to FDA on ezogabine


Issued: Monday 18 April 2011, London UK, Research Triangle Park, NC & Mississauga, Ontario

GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) submitted on 15 April 2011 the response to the U.S. Food and Drug Administration (FDA) Complete Response letter received on 30 November 2010 for the New Drug Application (NDA) for ezogabine*.

Ezogabine is an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

For announcements regarding the regulatory status, including filing and approval information, of ezogabine outside the US (where it is called retigabine*), please visit www.gsk.com and www.valeant.com .

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 www.gsk.com

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 www.valeant.com .

* Editor's note

Ezogabine is the non-proprietary name adopted by the United States Adopted Name Council for use in the U.S. and Canada. Retigabine is the non-proprietary name adopted by the International Nonproprietary Name for Pharmaceuticals Substances Program for use in the rest of the world.   

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