The first generic version of type 2 diabetes drug, Actos has been approved by the US Food and Drug Administration to help improve blood glucose control in diabetes patients.
The agency revealed that it has given 180-day exclusivity to Ranbaxy Pharmaceuticals and American drugmaker Mylan Inc to manufacture the drug in 15 milligram, 30 mg and 45 mg strengths. Actos tablets have annual sales of $2.7 billion in the United States.
Announcing the approval Gregory Geba, from the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research said, "Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes. Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition."