FDA approves generic versions of diabetes drug Actos

The first generic versions of the type 2 diabetes medication Actos have been approved for launch in the US market.
Earlier this week, the country’s Food and Drug Administration (FDA) granted India-based Ranbaxy Laboratories, Israel-headquartered Teva Pharmaceutical Industries and US-based Mylan Pharmaceuticals ‘first-to-file’ rights in America to sell generic forms of the drug for the next six months.
The generic tablets contain the same active ingredient as Actos (pioglitazone), which helps adult patients with type 2 diabetes improve blood glucose control by decreasing insulin resistance.
“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” said Gregory Geba, MD, director of the FDA’s 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 FDA stressed that the generic forms of pioglitazone are of the “same strength and quality” as its branded counterpart, which is made by Takeda Pharmaceuticals – the US subsidiary of Japan’s largest pharmaceutical company.
Actos has become one of the world’s biggest-selling diabetes medicines, with sales of the product totalling $2.7 billion in the US last year. However, sales for Takeda are now expected to nosedive following the FDA’s decision to approve three copycat versions of the blockbuster drug.