Crestor Safety Data Under FDA Review; 11 Reports Of Rhabdomyolysis At 10 Mg Dose
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency appears unlikely to make a significant change in the regulatory status of the statin in the near term; FDA notes that most of the reported cases of rhabdomyolysis and renal failure could be attributed to the underlying disease or concomitant medications. Public Citizen renews call for Crestor's withdrawal in Lancet article.
You may also be interested in...
Vytorin Managed Care Outlook More Positive Than Crestor, Survey Finds
Merck/Schering's Zocor/Zetia fixed-dose combo is likely to have coverage in one of the top two tiers in up to 50% of managed care plans six to 12 months post-launch, a Prudential survey finds. Crestor has coverage in top two tiers for about 30% of plans after one year on the market.
Vytorin Managed Care Outlook More Positive Than Crestor, Survey Finds
Merck/Schering's Zocor/Zetia fixed-dose combo is likely to have coverage in one of the top two tiers in up to 50% of managed care plans six to 12 months post-launch, a Prudential survey finds. Crestor has coverage in top two tiers for about 30% of plans after one year on the market.
AstraZeneca Questions Reliability Of Crestor Adverse Event Reports
A Public Citizen petition seeking withdrawal of rosuvastatin is “based on inappropriate and misleading interpretations of selective and incomplete data,” CEO McKillop says. AstraZeneca asserts Crestor’s adverse event profile is similar to other statins.