GSK Responds to FDA decision on Avandia (rosiglitazone)

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.