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Mylan Pharmaceuticals, Inc. (MYL) Gets FDA Approval for Generic Diabetes Med


8/17/2012 12:21:22 PM

August 17, 2012 -- The U.S. Food and Drug Administration today approved the first generic version of Actos (pioglitazone hydrochloride) tablets. 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.

Pioglitazone is dispensed with a patient Medication Guide that provides important instructions about its use and drug safety information. The drug has a Boxed Warning to emphasize that pioglitazone may cause or worsen heart failure, particularly in certain patient populations. Careful monitoring of patients when starting the drug or increasing the dose is recommended. The product label also notes that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

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.

Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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