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The FDA Approves Glucophage XR (Metformin HCl Extended Release Tablets)

PRINCETON, N.J., April 14 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Glucophage(R) XR (metformin HCl extended release tablets) 750 mg tablet, a new dosage strength of one of the leading type 2 diabetes therapies.

Glucophage XR, which was launched in October 2000, is a once-daily dosage form of Glucophage(R) (metformin hydrochloride tablets). Glucophage XR 750 mg was developed to provide physicians with an additional option to make titration to higher doses more convenient, when needed and appropriate. Glucophage XR is already available in a 500 mg strength and is approved together with diet and exercise for use as initial drug therapy to improve glycemic control for adults 17 years and older with type 2 diabetes when diet and exercise are not enough. In addition to initial therapy, Glucophage XR may be used in combination with a sulfonylurea or insulin to improve glycemic control. More than 10 million prescriptions have been written for Glucophage XR 500 mg.

According to the American Diabetes Association, approximately 16 million people in the United States have type 2 diabetes. People with type 2 diabetes are at increased risk for heart disease, stroke, blindness, kidney disease and other complications. In addition, the cost burden of diabetes is significant. A recent study found that the health problems caused by diabetes substantially increase health care expenditures and lost productivity associated with the disease.(1) Glucophage XR 750 mg provides another option for doctors and their patients to help manage this disease.

Glucophage XR (metformin HCl extended-release tablets) is not for everyone. In rare cases Glucophage XR may cause lactic acidosis, a serious condition caused by lactic acid build up in the blood. If it occurs, it can be fatal in up to half the cases. Lactic acidosis occurs mainly in people whose kidneys are not functioning properly. Patients should advise their doctor about alcohol use as this will increase the risk. Patients should not take these drugs if they have kidney problems, if they are 80 or older (unless they have their kidneys tested), if they are taking medication for heart failure, or if they have or had liver disease. The most common side effect of Glucophage XR is diarrhea.

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