Application Nr Approved Date Route Status External Links
NDA021612 2006-01-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lipofen Is A Peroxisome Proliferator Receptor Alpha (pparĪ±) Activator Indicated As An Adjunct To Diet: To Reduce Elevated Ldl-C, Total-C, Tg And Apo B, And To Increase Hdl-C In Adult Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia (1.1) To Reduce Triglycerides In Adult Patients With Severe Hypertriglyceridemia (1.2) Important Limitations Of Use: Fenofibrate At A Dose Equivalent To 150 Mg Of Lipofen Was Not Shown To Reduce Coronary Heart Disease Morbidity And Mortality In A Large, Randomized Controlled Trial Of Patients With Type 2 Diabetes Mellitus (5.1) 1.1 Primary Hypercholesterolemia Or Mixed Dyslipidemia Lipofen Is 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. 1.2 Severe Hypertriglyceridemia Lipofen Is Also Indicated As Adjunctive Therapy To Diet For Treatment Of Adult Patients With Severe Hypertriglyceridemia. Improving Glycemic Control In Diabetic Patients Showing Fasting Chylomicronemia Will Usually Obviate 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 At A Dose Equivalent To 150 Mg Of Lipofen Was Not Shown To Reduce Coronary Heart Disease Morbidity And Mortality In 2 Large, Randomized Controlled Trials Of Patients With Type 2 Diabetes Mellitus [see Warnings And Precautions(5.1)].

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved
2. Gelatin GELATIN Unresolved
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Shellac SHELLAC Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

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