FDA approves first generic Actos to treat type 2 diabetes


The US Food and Drug Administration has 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.

The manufacturer, Mylan Pharmaceuticals, gained FDA approval for 15mg, 30mg and 45mg pioglitazone tablets.

“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” said Gregory P Geba, 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.”

Pioglitazone box warning and recommendations state that the drug may cause or worsen heart failure, particularly in certain patient populations, therefore 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.