(By Balachander) U.S. health regulators have approved the first generic version of Takeda Pharmaceutical's diabetes drug Actos.
Mylan Inc. (NASDAQ:MYL) gained approval from the U.S. Food and Drug Administration (FDA) for 15 milligram, 30 mg and 45 mg Actos (pioglitazone) tablets used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
The brand product, which is the generic version of Japan's Takeda, had annual sales of roughly $2.7 billion in the United States.
Other generic drugmakers Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Ranbaxy Laboratories have commenced the sale of generic versions of Actos.
Meanwhile, Watson Pharmaceuticals Inc. (NYSE:WPI), which intended to sell the type 2 diabetes treatment, has sued the FDA regarding delay of approval of the generic drug.
According to the FDA, the most common side effects reported by patients using pioglitazone include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.
"Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition," said Gregory Geba, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research.