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GSK and Valeant announce receipt of U.S. FDA Complete Response letter for ezogabine

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) 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.

Issued: London, UK, Research Triangle Park, NC & Mississauga, Ontario

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) 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.

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

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 www.valeant.com.

GlaxoSmithKline Enquiries:

   

UK Media enquiries:

David Mawdsley

(020) 8047 5502

 

Claire Brough

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Jo Revill

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Jennifer Armstrong

(919) 483 2839

 

   

European Analyst/

Sally Ferguson

(020) 8047 5543

Investor enquiries:

Gary Davies

(020) 8047 5503

 

Ziba Shamsi

(020) 8047 3289

     

US Analyst/ Investor

Tom Curry

(215) 751 5419

Investor enquiries:

Jen Hill Baxter

(215) 751 7002

     

Valeant Enquiries:

Laurie W. Little

(949) 461 6002