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(Multimedia Version): Abbott Receives FDA Approval for TRILIPIX(TM) (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management
Date:12/15/2008

eneca are working together to develop a fixed-dose combination of Abbott's TRILIPIX and AstraZeneca's CRESTOR(R) (rosuvastatin calcium) with plans to submit a new drug application to the FDA in 2009. The companies also recently announced an agreement under which Abbott's sales force will co-promote CRESTOR in the United States.

TRILIPIX Indications

TRILIPIX is a prescription medicine used along with diet in adults to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can be used alone or with another cholesterol-lowering medicine called a statin. TRILIPIX has not been shown to prevent heart disease or heart attack.

Important Safety Information About TRILIPIX

TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient. Unexplained muscle pain, tenderness, or weakness may be a sign of a serious side effect and should be reported to a healthcare provider right away. Rarely, muscle-related problems can cause kidney damage. These side effects may be increased when TRILIPIX is used with a statin. Patients should tell their healthcare provider about all the medicines they take to help avoid serious side effects. Blood tests may be performed before and during treatment with TRILIPIX. Patients should contact their healthcare provider if they experience abdominal pain, nausea or vomiting while taking TRILIPIX. These may be signs of inflammation of the gallbladder or pancreas. Women who are pregnant should not take statins and should talk with their healthcare provider about TRILIPIX if they are pregnant or may become pregnant. The most common side effects with TRILIPIX include headache, heartburn, nausea, muscle aches and increases in muscle or liver enzymes that are measured by blood tests. Full Prescribing Information is available at

SOURCE Abbott
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