First generic version of cholesterol-lowering Lipitor approved

December 1, 2011

FDA approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).

FDA approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).

Ranbaxy Laboratories has gained approval to make generic atorvastatin calcium tablets in 10-mg, 20-mg, 40-mg, and 80-mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, NJ.

"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, MD, director of 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."

Not all cholesterol in your blood is bad. There are 3 kinds of blood cholesterol: high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. HDL (good cholesterol) helps keep cholesterol from building up in the arteries. LDL (bad cholesterol) is the main source of cholesterol buildup and blockage in the arteries, which can prevent proper blood flow to your heart and lead to a heart attack. Triglycerides can lead to hardening of the arteries.

Atorvastatin is a statin, a type of drug that lowers cholesterol in the body by blocking an enzyme in the liver. Atorvastatin is used along with a low-fat diet to lower the LDL cholesterol and triglycerides in the blood. The drug can raise HDL cholesterol as well. 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.

Mylan, Teva, and Dr Reddy’s Laboratories are among generic-drug makers seeking FDA approval to sell generic Lipitor after Ranbaxy’s 6-month exclusivity expires, according to US court filings.

For more information on FDA: Understanding Generic Drugs, click here.