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

urgery, 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
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SOURCE U.S. Food and Drug Administration
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