FDA approves first generic Actos to treat type 2 diabetes

FDA approved Mylan Pharmaceutical’s 15-mg, 30-mg, and 45-mg pioglitazone hydrochloride tablets (Pioglitazone HCl Safety Information), the first generic version of Actos (Takeda), along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

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

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.