Application Nr Approved Date Route Status External Links
NDA021695 2013-10-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Fenofibrate Is A Peroxisome Proliferator Receptor Alpha (pparĪ±) Activator Indicated As An Adjunct To Diet: To Reduce Elevated Ldl-C, Total-C, Triglycerides, And Apo B, And To Increase Hdl-C In Adult Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia (1.1). To Reduce Triglyceride (tg) Levels In Adult Patients With Severe Hypertriglyceridemia (1.2). Important Limitations Of Use: Fenofibrate Was Not Shown To Reduce Coronary Heart Disease Morbidity And Mortality In Patients With Type 2 Diabetes Mellitus (5.1). 1.1 Primary Hypercholesterolemia And Mixed Dyslipidemia Fenofibrate Capsules Is Indicated As Adjunctive Therapy To Diet To Reduce Elevated Low-Density Lipoprotein Cholesterol (ldl-C), Total Cholesterol (total-C), Triglycerides (tg), And Apolipoprotein B (apo B), And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Adult Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia. 1.2 Severe Hypertriglyceridemia Fenofibrate Capsules Is Also Indicated As Adjunctive Therapy To Diet For Treatment Of Adult Patients With Hypertriglyceridemia. Improving Glycemic Control In Diabetic Patients Showing Fasting Chylomicronemia Will Usually Reduce Fasting Triglycerides And Eliminate Chylomicronemia Thereby Obviating The Need For Pharmacologic Intervention. Markedly Elevated Levels Of Serum Triglycerides (e.g. > 2,000 Mg/dl) May Increase The Risk Of Developing Pancreatitis. The Effect Of Fenofibrate Therapy On Reducing This Risk Has Not Been Adequately Studied. 1.3 Important Limitations Of Use Fenofibrate Was Not Shown To Reduce Coronary Heart Disease Morbidity And Mortality In Patients With Type 2 Diabetes Mellitus [see Warnings And Precautions (5.1)].

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
3. Dimethicone DIMETHICONE Molecular
4. Simethicone SIMETHICONE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fenofibrate FENOFIBRATE ZINC584092

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