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Generic version of pioglitazone receives FDA approval
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The FDA announced today that it has approved the first generic version of pioglitazone tablets, which are used in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes.
According to a press release, Mylan Pharmaceuticals gained FDA approval for the 15 mg, 30 mg and 45 mg tablets.
“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 the FDA’s Center for Drug Evaluation and Research, said in the 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 (Actos, Takeda) is dispensed with a patient medication guide that provides important instructions about its use and drug safety information. The drug also has a boxed warning to emphasize that pioglitazone may cause or worsen heart failure, particularly in certain patient populations. The agency recommends careful monitoring of patients when starting the drug or increasing the dosage. Additionally, the product label states that the use of pioglitazone for more than 1 year is associated with the risk of bladder cancer.
The most common side effects reported by patients using pioglitazone include headache, sinus infection, muscle pain and sore throat.
Information about the availability of generic pioglitazone can be obtained from the manufacturer.