Published March 19, 2010 MEDICATION MANAGEMENT FDA Approves Statin for Primary CVD Prevention By staff US Pharm. 2010;35(3):5. Silver Spring, MD -- The FDA has approved rosuvastatin (Crestor) for the primary prevention of cardiovascular disease (CVD), making it the first statin to receive this indication. The new labeling is also the first to include an indication based on the inflammatory biomarker C-reactive protein (CRP). The new indication would be for men aged 50 years or older and women aged 60 years or older who have a fasting LDL of less than 130 mg/dL, a highly sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke or risk of coronary heart disease. The basis for the new labeling was the JUPITER trial, a randomized, placebo-controlled trial sponsored by AstraZeneca, the drug's marketer, involving 17,802 men and women with a mean age of 66 and no history of atherosclerosis.