The U.S. Food and Drug Administration (FDA) has approved the first generic version of the highly popular cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).
Ranbaxy Laboratories Ltd. has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths.
This comes following the failure of manufacturers Pfizer to protect the US patent on the drug.
In Europe, however, Pfizer has managed to extend patent protection for another six months, to May 2012.
“This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” said Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research.
“We are working very hard to get generic drugs to people as soon as the law will allow.”
Atorvastatin lowers the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as age, smoking, high blood pressure, low HDL, or family history of early heart disease.
In the clinical trials for Lipitor, the most commonly reported adverse reactions in patients were: inflammation of the nasal passages, joint pain, diarrhea, and urinary tract infection.
The drug will be manufactured by Ohm Laboratories in New Brunswick, N.J.