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GSK Responds to FDA Decision on Avandia (rosiglitazone)

GSK announced today that the U.S. Food and Drug Administration (FDA) has eased restrictions on patient access to Avandia (rosiglitazone), following an FDA Advisory Committee review in June 2013.

Issued: London UK

GSK plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has eased restrictions on patient access to Avandia (rosiglitazone), following an FDA Advisory Committee review in June 2013.

GSK welcomes the decision of the FDA and appreciates the Agency’s robust review of the science with regard to Avandia. GSK maintains its view that Avandia is a safe and effective treatment for Type 2 diabetes when used appropriately.

The company will work with the FDA to update labeling and to implement the Agency’s decisions regarding easing restrictions on the medicine.

GSK – 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.

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors  in the company's Annual Report on Form 20-F for 2012.