ONGLYZA has been submitted for regulatory review in more than 58 countries and is approved in 43 countries, including the United States, Canada, Mexico, 30 EU countries, Chile, India, Brazil, Argentina and Switzerland. ONGLYZA was approved by the FDA in July 2009 and is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. ONGLYZA once daily used in combination with commonly prescribed oral anti-diabetic medications - metformin, glyburide (a sulfonylurea) or a thiazolidinedione (TZD), (pioglitazone or rosiglitazone) - or as a monotherapy statistically significantly reduced HbA1c levels. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). ONGLYZA (saxagliptin) has not been studied in combination with insulin.

Source: ASTRAZENECA and BRISTOL-MYERS SQUIBB