Application Nr Approved Date Route Status External Links
ANDA203899 2017-06-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Therapy With Lipid-Altering Agents Should Be Only One Component Of Multiple Risk Factor Intervention In Individuals At Significantly Increased Risk For Atherosclerotic Vascular Disease Due To Hyperlipidemia. Niacin Therapy Is Indicated As An Adjunct To Diet When The Response To A Diet Restricted In Saturated Fat And Cholesterol And Other Nonpharmacologic Measures Alone Has Been Inadequate. 1. Niacin Extended-Release Tablets Is Indicated To Reduce Elevated Tc, Ldl-C, Apo B And Tg Levels, And To Increase Hdl-C In Patients With Primary Hyperlipidemia And Mixed Dyslipidemia. 2. In Patients With A History Of Myocardial Infarction And Hyperlipidemia, Niacin Is Indicated To Reduce The Risk Of Recurrent Nonfatal Myocardial Infarction. 3. In Patients With A History Of Coronary Artery Disease (cad) And Hyperlipidemia, Niacin, In Combination With A Bile Acid Binding Resin, Is Indicated To Slow Progression Or Promote Regression Of Atherosclerotic Disease. 4. Niacin Extended-Release Tablets In Combination With A Bile Acid Binding Resin Is Indicated To Reduce Elevated Tc And Ldl-C Levels In Adult Patients With Primary Hyperlipidemia. 5. Niacin Is Also Indicated As Adjunctive Therapy For Treatment Of Adult Patients With Severe Hypertriglyceridemia Who Present A Risk Of Pancreatitis And Who Do Not Respond Adequately To A Determined Dietary Effort To Control Them. Limitations Of Use Addition Of Niacin Extended-Release Tablets Did Not Reduce Cardiovascular Morbidity Or Mortality Among Patients Treated With Simvastatin In A Large, Randomized Controlled Trial (aim-High) [see Warnings And Precautions( 5.1 )]. Niacin Extended-Release Tablets Contains­ Extended-Release Niacin (nicotinic Acid), And Is Indicated: To Reduce Elevated Tc, Ldl-C, Apo B And Tg, And To Increase Hdl-C In Patients With Primary Hyperlipidemia And Mixed Dyslipidemia. (1) To Reduce The Risk Of Recurrent Nonfatal Myocardial Infarction In Patients With A History Of Myocardial Infarction And Hyperlipidemia. (1) In Combination With A Bile Acid Binding Resin: Slows Progression Or Promotes Regression Of Atherosclerotic Disease In Patients With A History Of Coronary Artery Disease (cad) And Hyperlipidemia. (1) As An Adjunct To Diet To Reduce Elevated Tc And Ldl-C In Adult Patients With Primary Hyperlipidemia. (1) To Reduce Tg In Adult Patients With Severe Hypertriglyceridemia. (1) Limitations Of Use: Addition Of Niacin Extended-Release Tablets Did Not Reduce Cardiovascular Morbidity Or Mortality Among Patients Treated With Simvastatin In A Large, Randomized Controlled Trail. (5.1)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Lecithin LECITHIN Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Niacin NIACIN ZINC1795

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