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FDA Approves First Generic Version of Cholesterol-Lowering Drug Lipitor
Date:11/30/2011

SILVER SPRING, Md., Nov. 30, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).

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

People who have high blood cholesterol levels have a greater chance of getting heart disease. By itself, the condition usually has no signs or symptoms. Thus, many people do not know that their cholesterol levels are too high.

"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, M.D., 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."

Not all cholesterol in your blood is bad. There are three kinds of blood cholesterol that you should know about: 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.

Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic atorvastatin can be obtained from Ranbaxy.  

For more information:

FDA: Understanding Generic Drugs
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm

National Heart Lung and Blood Institute: What is Cholesterol?
http://www.nhlbi.nih.gov/health/health-topics/topics/hbc/

Information on specific drug products, Drugs@FDA
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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