FDA approves first generic Actos to treat type 2 diabetes

The U.S. Food and Drug Administration approved the first generic version of Actos (pioglitazone hydrochloride) tablets on Aug. 17. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes.

Mylan Pharmaceuticals, based in Morgantown, W.Va., gained FDA approval for 15 milligram, 30 mg and 45 mg pioglitazone tablets.

“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” said Gregory P. Geba, M.D., M.P.H., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”

Diabetes is a disease in which blood glucose, or sugar, levels are too high. Glucose comes largely from the food we eat. Insulin is a hormone that helps move glucose into the body’s cells to help them produce energy. In people with type 2 diabetes the body does not make or use insulin well. Without enough insulin, glucose stays in the blood. Over time, too much glucose in the blood can cause serious health problems such as damage to eyes, kidneys, and nerves. Diabetes can also contribute to heart disease, and stroke.

The most common side effects reported by patients using pioglitazone include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat. Information about the availability of generic pioglitazone can be obtained from the manufacturer.