FDA approves first generic Actos to treat diabetes

Hannah Blake

pharmaphorum

The first generic version of Takeda Pharmaceutical’s diabetes drug, Actos (pioglitazone hydrochloride), has been approved by the FDA. US-based Mylan Pharmaceuticals gained FDA approval for 15 milligram, 30 mg and 45 mg pioglitazone tablets. Along with diet and exercise, pioglitazone is used 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. Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”

Gregory P. Geba, M.D., M.P.H., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

Generic drugs approved by the FDA are of the same high quality and strength as brand-name drugs. As with the brand-name drug, Mylan’s generic version of Actos will carry the label warning that it could cause or worsen heart failure in certain patients.

Last week it was announced that the FDA had denied Watson Pharmaceuticals’ generic version of Actos, which was due to be launched at the same time as Mylan’s. Watson is now filing a lawsuit against the FDA.