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Drug Information Update- Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial


FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


FDA is approving a new indication for the cholesterol lowering medication CRESTOR (rosuvastatin). CRESTOR will now be indicated for the primary prevention of cardiovascular disease to reduce the risk of stroke, heart attack, and the risk of arterial revascularization procedures (including coronary artery bypass graft, or bypass grafting of a peripheral artery or carotid artery, or angioplasty or stent placement) in individuals who have no clinically evident heart disease but are at an increased risk of heart disease due to the combined effect of the following risk factors:

– Age (> 50 years in men; > 60 years in women), and
– An elevated high-sensitivity C-reactive protein level (> 2 mg/L), and
– Presence of at least one additional cardiovascular risk factor (e.g., high blood pressure, low HDL-C, smoking, or a family history of premature heart disease).
CRESTOR is in a class of drugs called “statins.” Statins work by stopping an enzyme called HMG-CoA reductase from making cholesterol. High cholesterol is a known risk factor for heart attacks and strokes.

For more information, please visit: Crestor


February 11, 2010 - Posted by | 1

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