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Generic Tricor is used for controlling high cholesterol and triglyceride levels in the blood.
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The efficacy of fenofibrate has been closely scrutinized in light of several studies that suggest that the lipid-modifying drug does little to reduce the risk of cardiovascular disease. Fibrates are a class of medications that target genes involved in lipid metabolism. The relevance of the earlier fibrates — clofibrate and gemfibrozil — to practice today is limited: clofibrate is no longer available in the U. Fenofibrate, the most commonly used medication in the class, was developed by Fournier Laboratories in the s. Fournier never marketed the drug in the U. Branded drugs are usually protected from competition for several years after approval, allowing their prices to be set at almost any level, in order to reward drug makers for their investment in the research and development process. Patent protection and data exclusivity work together to do this, as detailed in e-Appendix 1. Alternatively, generic drug makers can challenge remaining patents by making a special certification in their ANDAs e-Appendix 1. By law, this action requires the FDA to delay approval of the ANDAs by up to 30 months to give the legal system an opportunity to resolve the dispute, meaning that the branded drug maker remains protected from generic competition during this time. Abbott rapidly responded by filing a patent infringement suit, which legally delayed the approval of this ANDA by 30 months or until the litigation was resolved, thus protecting Tricor-1 from competition e-Appendix 2.
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Fenofibrate Capsules USP are a lipid regulating agent available as hard gelatin capsules for oral administration. Each hard gelatin capsule contains 50 or mg of fenofibrate USP. Fenofibrate is a white solid which is stable under ordinary conditions. Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol LDL -C, total cholesterol total-c, Triglycerides TG and apolopoprotein B Apo B, and to increase high-density lipoprotein cholesterol HDL -C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.
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