Diabetes drug Actos will soon be available as cheaper generic

By Deborah Kotz, Globe Staff

The US Food and Drug Administration gave the green light Friday to the first generic version of the blockbuster diabetes drug Actos (pioglitazone hydrochloride). It’s often taken as a second-line treatment for type 2 diabetes among those who don’t get a big enough blood sugar level drop with a first-line therapy such as metformin.

A generic version of the combination drug pioglitazone plus metformin (Actoplus Met), was approved by the FDA last year and is currently available.

The generic pioglitazone will be available in 15 milligram, 30 mg and 45 mg tablets and should become available as a prescription within a few months.

“Controlling blood sugar is very important in preventing or reducing the long-term health complications of diabetes,” said Dr. Gregory P. Geba, the FDA’s director of the Office of Generic Drugs. “Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”

The generic versions of pioglitazone and pioglitazone plus metformin are made by Mylan Pharmaceuticals. Consumers usually save 30 to 80 percent on generic medications compared to brand name versions.

Pioglitazone has a boxed warning that alerts patients the drug may worsen heart failure and may be associated with an increased risk of bladder cancer.

The most common side effects reported include nasal congestion, headache, sinus infection, muscle pain, and sore throat.