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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)...

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AstraZeneca Crestor

AstraZeneca cholesterol agent Crestor (rosuvastatin) has a user fee action deadline in August, after the company submitted additional data on 10 mg to 40 mg doses to FDA Feb. 12. AstraZeneca received an "approvable" letter for Crestor May 31, 2002 (1"The Pink Sheet" June 10, 2002, In Brief)...

AstraZeneca Crestor Post-NDA Studies Focusing On 40 Mg Dose

AstraZeneca's ongoing trials of Crestor are focusing on 40 mg as the maximum dose of the cholesterol-lowering drug

AstraZeneca Crestor 80 Mg Dose Would Have Low Demand, CEO Suggests

AstraZeneca expects that an 80 mg strength of Crestor, if approved, would constitute a small proportion of the product's sales




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