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www.fdanews.com/articles/136949-fda-panel-agrees-on-new-study-for-abbott-8217-s-trilipix

FDA Panel Agrees on New Study for Abbott’s Trilipix

May 20, 2011
An FDA Advisory Committee is requesting Abbott conduct a new clinical study for its cholesterol-lowering drug Trilipix, but split on the agency’s actions for the drug’s indication. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously Thursday that the agency should require Abbott to conduct a clinical trial to test high-risk men and women on a statin with high triglycerides (TGs) and low high-density lipoprotein (HDL) to see if the addition of Trilipix (fenofibric acid) would lower the risk for cardiovascular risks.
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