Application Nr Approved Date Route Status External Links
ANDA201573 2013-07-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fenofibric Acid Delayed-Release Capsules Are A Peroxisome Proliferator-Activated Receptor (ppar) Alpha Agonist Indicated As Adjunctive Therapy To Diet To: •reduce Tg In Patients With Severe Hypertriglyceridemia ( 1.1 ). •reduce Elevated Ldl-C, Total-C, Tg And Apo B, And To Increase Hdl-C In Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia ( 1.2 ). Limitations Of Use: Fenofibrate At A Dose Equivalent To 135 Mg Of Fenofibric Acid Delayed-Release Capsules Did Not Reduce Coronary Heart Disease Morbidity And Mortality In Patients With Type 2 Diabetes Mellitus (5.1). 1.1 Treatment Of Severe Hypertriglyceridemia Fenofibric Acid Delayed-Release Capsules Are Indicated As Adjunctive Therapy To Diet To Reduce Triglycerides (tg) In Patients With Severe Hypertriglyceridemia. Improving Glycemic Control In Diabetic Patients Showing Fasting Chylomicronemia Will Usually Obviate The Need For Pharmacological Intervention. Markedly Elevated Levels Of Serum Triglycerides (e.g., > 2,000 Mg/dl) May Increase The Risk Of Developing Pancreatitis. The Effect Of Fenofibric Acid Delayed-Release Capsules Therapy On Reducing This Risk Has Not Been Adequately Studied. 1.2 Treatment Of Primary Hypercholesterolemia Or Mixed Dyslipidemia Fenofibric Acid Delayed-Release Capsules Are 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 Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia. 1.3 Limitations Of Use Fenofibrate At A Dose Equivalent To 135 Mg Of Fenofibric Acid Delayed-Release Capsules Did Not 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) ]. 1.4 General Considerations For Treatment Laboratory Studies Should Be Performed To Establish That Lipid Levels Are Abnormal Before Instituting Fenofibric Acid Delayed-Release Capsules Therapy. Every Reasonable Attempt Should Be Made To Control Serum Lipids With Non-Drug Methods Including Appropriate Diet, Exercise, Weight Loss In Obese Patients, And Control Of Any Medical Problems Such As Diabetes Mellitus And Hypothyroidism That May Be Contributing To The Lipid Abnormalities. Medications Known To Exacerbate Hypertriglyceridemia (beta-Blockers, Thiazides, Estrogens) Should Be Discontinued Or Changed If Possible, And Excessive Alcohol Intake Should Be Addressed Before Triglyceride-Lowering Drug Therapy Is Considered. If The Decision Is Made To Use Lipid-Altering Drugs, The Patient Should Be Instructed That This Does Not Reduce The Importance Of Adhering To Diet. Drug Therapy Is Not Indicated For Patients Who Have Elevations Of Chylomicrons And Plasma Triglycerides, But Who Have Normal Levels Of Vldl.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
4. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
7. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
8. 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. Choline Fenofibrate

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