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FDA Approves Saxagliptin for Type 2 Diabetes ROCKVILLE, Md -- July 31, 2009 -- The US Food and Drug Administration (FDA) has approved once-daily saxagliptin (Onglyza) tablets for the treatment of type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels. “Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with type 2 diabetes,” said Mary Parks, MD, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.” The most common side effects observed with saxagliptin are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives. Approval was primarily based on the results of 8 clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although saxagliptin was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a post-market study that will specifically evaluate cardiovascular safety in a higher risk population. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version