Application Nr Approved Date Route Status External Links
ANDA077987 2007-12-28 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 Hypercholesterolemia. Drug 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. Pravastatin Sodium Tablets Are An Hmg-Coa Reductase Inhibitor (statin) Indicated As An Adjunctive Therapy To Diet To: Reduce The Risk Of Mi, Revascularization, And Cardiovascular Mortality In Hypercholesterolemic Patients Without Clinically Evident Chd. ( 1.1) Reduce The Risk Of Total Mortality By Reducing Coronary Death, Mi, Revascularization, Stroke/tia, And The Progression Of Coronary Atherosclerosis In Patients With Clinically Evident Chd. ( 1.1) Reduce Elevated Total-C, Ldl-C, Apob, And Tg Levels And To Increase Hdl-C In Patients With Primary Hypercholesterolemia And Mixed Dyslipidemia. ( 1.2) Reduce Elevated Serum Tg Levels In Patients With Hypertriglyceridemia. ( 1.2) Treat Patients With Primary Dysbetalipoproteinemia Who Are Not Responding To Diet. ( 1.2) Treat Children And Adolescent Patients Ages 8 Years And Older With Heterozygous Familial Hypercholesterolemia After Failing An Adequate Trial Of Diet Therapy. ( 1.2) Limitations Of Use: Pravastatin Sodium Tablets Have Not Been Studied In Fredrickson Types I And V Dyslipidemias. ( 1.3) 1.1 Prevention Of Cardiovascular Disease In Hypercholesterolemic Patients Without Clinically Evident Coronary Heart Disease (chd), Pravastatin Sodium Tablets Are Indicated To: Reduce The Risk Of Myocardial Infarction (mi). Reduce The Risk Of Undergoing Myocardial Revascularization Procedures. Reduce The Risk Of Cardiovascular Mortality With No Increase In Death From Non-Cardiovascular Causes. In Patients With Clinically Evident Chd, Pravastatin Sodium Tablets Are Indicated To: Reduce The Risk Of Total Mortality By Reducing Coronary Death. Reduce The Risk Of Mi. Reduce The Risk Of Undergoing Myocardial Revascularization Procedures. Reduce The Risk Of Stroke And Stroke/transient Ischemic Attack (tia). Slow The Progression Of Coronary Atherosclerosis. 1.2 Hyperlipidemia Pravastatin Sodium Tablets Are Indicated: As An Adjunct To Diet To Reduce Elevated Total Cholesterol (total-C), Low-Density Lipoprotein Cholesterol (ldl-C), Apolipoprotein B (apob), And Triglyceride (tg) Levels And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Patients With Primary Hypercholesterolemia And Mixed Dyslipidemia ( Fredrickson Types Iia And Iib). 1 As An Adjunct To Diet For The Treatment Of Patients With Elevated Serum Tg Levels ( Fredrickson Type Iv). For The Treatment Of Patients With Primary Dysbetalipoproteinemia ( Fredrickson Type Iii) Who Do Not Respond Adequately To Diet. As An Adjunct To Diet And Lifestyle Modification For Treatment Of Heterozygous Familial Hypercholesterolemia (hefh) In Children And Adolescent Patients Ages 8 Years And Older If After An Adequate Trial Of Diet The Following Findings Are Present: Ldl-C Remains ≥190 Mg/dl Or Ldl-C Remains ≥160 Mg/dl And: There Is A Positive Family History Of Premature Cardiovascular Disease (cvd) Or Two Or More Other Cvd Risk Factors Are Present In The Patient. 1.3 Limitations Of Use Pravastatin Sodium Tablets Have Not Been Studied In Conditions Where The Major Lipoprotein Abnormality Is Elevation Of Chylomicrons ( Fredrickson Types I And V).

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
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. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
4. Meglumine MEGLUMINE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pravastatin Sodium PRAVASTATIN SODIUM ZINC3798763

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