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Category: Health News

Washington, DC - The U.S. Food and Drug Administration Friday approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses:

High LDL cholesterol, the so-called “bad cholesterol,” is a known risk factor for heart attacks, strokes, and heart disease. High triglycerides may also increase the risk of heart disease.

“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA requires that generic drugs meet rigorous scientific and quality standards.”

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

Watson Pharmaceuticals Inc. of Parsippany, New Jersey has received approval to market generic rosuvastatin calcium in multiple strengths.

Rosuvastatin calcium is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. Statins should be used in addition to a diet restricted in saturated fat and cholesterol.

In the clinical trials for Crestor, the most common side effects reported by participants taking Crestor included headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea.

Rosuvastatin calcium should not be used in women who are pregnant or may become pregnant as it may cause fetal harm. Women who require treatment with rosuvastatin should be advised not to nurse their infants.

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.