AstraZeneca Crestor is “approvable”
Executive Summary
AstraZeneca receives "approvable" letter for Crestor (rosuvastatin) May 31, a month ahead of the 12-month review deadline. The company expected an "approvable" letter from FDA for the statin, whose 80 mg dose has been associated with rhabdomyolysis (1"The Pink Sheet" Feb. 4, p. 25)...