FDA Approves New Lipid Lowering Combination Tablet
The Food and Drug Administration (FDA) has approved a new lipid-lowering combination tablet (Liptruzet) that includes atorvastatin, which went off patent in 2011, and ezetimibe.
This is the third time that the FDA has considered Liptruzet. The agency rejected Merck's application for the drug in 2009. In 2012, it issued a complete-response letter stating it would not approve the combination tablet and that more data were needed. To date, no incremental benefit of the new combination drug on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established to date. A combination tablet (Vytorin) that includes simvastatin and ezetimibe is already available in the US.
Keywords: Pyrroles, Cholesterol, Drug Combinations, United States Food and Drug Administration, Azetidines, Hyperlipoproteinemia Type II, Bile, Heptanoic Acids, Simvastatin
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