The FDA approved the first generic version of Actos (pioglitazone hydrochloride) tablets on Aug. 17 to improve blood glucose control in adults with type 2 diabetes. This approval came in the same week that Watson Pharmaceuticals sued the FDA for not approving the generic drug quickly enough.
Mylan Pharmaceuticals, based in Morgantown, W.Va., gained FDA approval for 15 mg, 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, MD, MPH, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, in a 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. The 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.
The agency noted that that generic drugs its approves "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.