AstraZeneca's cholesterol-lowerer Crestor finally gains FDA approval
The US Food and Drug Administration has granted long-awaited marketing authorization to Crestor (rosuvastatin), AstraZeneca's cholesterol-lowering agent. The product is indicated as an adjunct to diet for the treatment of a range of lipid disorders, including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia, noted the company.
The decision follows the unanimous recommendation for approval by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on July 9 (Marketletter July 14). The FDA has approved a recommended starting dose of 10mg once-daily, with a dose range of 5mg-40mg available.
Delay over safety issues
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