FDA Cmte. Likes Vytorin Safety In SHARP, But Worries About Dose Escalation
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FDA Cmte. To Weigh Breadth Of Vytorin/Zetia CV Risk Reduction Claim In Renally Impaired Patients
The Endocrinologic and Metabolic Drugs Advisory Committee will vote Nov. 2 on whether a new claim for reducing the risk of major cardiovascular events based upon the SHARP study should apply to both the pre-dialysis and dialysis populations.
SEARCH Ends Badly For Simvastatin 80 Mg; FDA Restricts Use To Existing Patients
New clinical trial data and adverse event reports show high-dose simvastatin-containing products have a greater risk for muscle toxicity than other statins, the agency concludes.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.