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Wednesday, December 16, 2009

FDA advisory panel votes in favor of broadened rosuvastatin indication

The Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 12 to 4 today, with one abstention, in favor of broadening the indication for rosuvastatin (Crestor, AstraZeneca) to include patients with normal LDL-cholesterol levels but who are at low to moderate risk for cardiovascular disease based on other risk factors, most notably elevated levels of high-sensitivity C-reactive protein (hs-CRP).

Specifically, the advisory panel felt there was sufficient evidence of benefit to justify the risks of prescribing rosuvastatin in men >50 years old and women >60 years old who had fasting LDL-cholesterol levels <130 mg/dL, hs-CRP >2.0 mg/dL, triglycerides <500 mg/dL, and no prior


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