FDA Approves Generic Actos
August 19, 2012

Generic Version Of Diabetes Drug Actos Approved By FDA

redOrbit Staff & Wire Reports - Your Universe Online

The US Food and Drug Administration (FDA) has approved the first generic version of the prescription drug Actos, which is used by adults with type 2 diabetes to help control blood glucose levels.

The FDA granted a license to produce generic Actos, also know pioglitazone, to Morgantown, West Virginia-based Mylan Pharmaceuticals, HealthDay News reported on Friday. They will produce the medication in 15mg, 30mg, and 45mg strengths.

"Pioglitazone carries a warning about the risk that it may cause or worsen heart failure, and that using pioglitazone for more than one year may be linked to a higher risk of bladder cancer," Sonam Vashi of WebMD Health News said. "The FDA recommends careful monitoring of patients when starting the drug or increasing the dosage“¦ The most common side effects of pioglitazone include sinus infection, muscle pain, headache, and sore throat."

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

Type 2 diabetes is a disease in which blood sugar levels are too high -- a direct result of the body's inability to make or utilize insulin well. Due to problems with producing or using the hormone, which is produced in the pancreas, glucose remains in the patient's blood. Over time, those elevated blood glucose levels result in eye, kidney, or nerve damage, as well as cardiovascular disease, stroke, or other ailments.

"Mylan's immediate launch of these products is representative of the company's ongoing commitment to expand access to high quality, more affordable medicines," CEO Heather Bresch said in a statement. "A crucial part of setting new standards in health care includes meeting patients' unmet needs, and we look forward to continuing to grow our portfolio of products for patients living with diabetes."