Mental Health

FDA Approves First Generic Drug to Treat Type 2 Diabetes

By Staff Reporter | Update Date: Aug 17, 2012 04:14 PM EDT

The U.S. Food and Drug Administration has approved the first generic version of Actos (pioglitazone hydrochloride 15 milligram, 30 mg and 45 mg ) tablets to be used to, along with diet and exercise, improve blood glucose control in adults with type 2 diabetes.

According to the FDA, diabetes is a disease in which blood sugar levels are too high. 

In people with type 2 diabetes, the body does not make or use insulin well. Without enough insulin, sugar stays in the blood. Over time, too much sugar 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.

Gregory P. Geba, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research said controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes. 

He also said generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.

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.

Mylan Pharmaceuticals, based in Morgantown, W.Va., gained FDA approval for 

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