AstraZeneca Crestor delay
Executive Summary
AstraZeneca expects an "approvable" letter for cholesterol agent Crestor (rosuvastatin) at the end of June, consistent with a 12-month user fee deadline, rather than original 10-month expectation. FDA is seeking data and analyses "to support the use of Crestor at higher doses," company says. The 80 mg dose was associated with rhabdomyolysis in Phase III trials (1"The Pink Sheet" Feb. 4, p. 25). The launch will be delayed beyond the third quarter...