AstraZeneca Crestor review
Executive Summary
AstraZeneca's statin Crestor (rosuvastatin) will be reviewed July 9 by FDA's Endocrinologic & Metabolic Drugs Advisory Committee for treatment of hypercholesterolemia and mixed dyslipidemia. In response to a May 2002 "approvable" letter, AstraZeneca submitted data on Feb. 12 on the 10 mg, 20 mg and 40 mg doses, giving the NDA a mid-August user fee goal (1"The Pink Sheet" May 5, p. 19). Development of an 80 mg dose was discontinued due to reports of rhabdomyolysis and renal impairment. The meeting will be held at the Holiday Inn in Bethesda, Md. at 8:30 a.m...
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AstraZeneca's statin Crestor (rosuvastatin) will be reviewed July 9 by FDA's Endocrinologic & Metabolic Drugs Advisory Committee for treatment of hypercholesterolemia and mixed dyslipidemia. In response to a May 2002 "approvable" letter, AstraZeneca submitted data on Feb. 12 on the 10 mg, 20 mg and 40 mg doses, giving the NDA a mid-August user fee goal (1 (Also see "Crestor 10 mg Dose Is Initial Focus In Canadian Marketing Campaign" - Pink Sheet, 5 May, 2003.) p. 19). Development of an 80 mg dose was discontinued due to reports of rhabdomyolysis and renal impairment. The meeting will be held at the Holiday Inn in Bethesda, Md. at 8:30 a.m.... |