Application Nr Approved Date Route Status External Links
NDA021192 2000-10-06 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 Non-Pharmacologic Measures Alone Has Been Inadequate. Lescol/lescol Xl Is An Hmg-Coa Reductase Inhibitor (statin) Indicated As An Adjunctive Therapy To Diet To: Reduce Elevated Tc, Ldl-C, Apo B, And Tg, And To Increase Hdl-C In Adult Patients With Primary Hypercholesterolemia And Mixed Dyslipidemia ( ) 1.1 Reduce Elevated Tc, Ldl-C, And Apo B Levels In Boys And Post-Menarchal Girls, 10 To 16 Years Of Age, With Heterozygous Familial Hypercholesterolemia After Failing An Adequate Trial Of Diet Therapy ( ) 1.1 Reduce The Risk Of Undergoing Revascularization Procedures In Patients With Clinically Evident Chd ( ) 1.2 Slow The Progression Of Atherosclerosis In Patients With Chd ( ) 1.2 Limitations Of Use: Neither Lescol Nor Lescol Xl Have Been Studied In Conditions Where The Major Abnormality Is Elevation Of Chylomicrons, Vldl, Or Idl (i.e., Hyperlipoproteinemia Types I, Iii, Iv, Or V) ( ) 1.3 1.1 Hypercholesterolemia (heterozygous Familial And Nonfamilial) And Mixed Dyslipidemia Lescol And Lescol Xl Are Indicated As An Adjunct To Diet To Reduce Elevated Total Cholesterol (total-C), Low-Density Lipoprotein Cholesterol (ldl-C), Triglyceride (tg) And Apolipoprotein B (apo B) Levels, And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Patients With Primary Hypercholesterolemia And Mixed Dyslipidemia (fredrickson Type Iia And Iib). As An Adjunct To Diet To Reduce Total-C, Ldl-C, And Apo B Levels In Adolescent Boys And Adolescent Girls Who Are At Least One Year Post-Menarche, 10-16 Years Of Age, With Heterozygous Familial Hypercholesterolemia And 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 Or Two Or More Other Cardiovascular Disease Risk Factors Are Present The Ncep Classification Of Cholesterol Levels In Pediatric Patients With A Familial History Of Hypercholesterolemia Or Premature Cvd Is Summarized Below. Category Total-C (mg/ Dl ) Ldl-C (mg/ Dl ) Acceptable <170 <110 Borderline 170-199 110-129 High ≥200 ≥130 Children Treated With Fluvastatin In Adolescence Should Be Re-Evaluated In Adulthood And Appropriate Changes Made To Their Cholesterol-Lowering Regimen To Achieve Adult Treatment Goals. 1.2 Secondary Prevention Of Cardiovascular Disease In Patients With Clinically Evident Chd, Lescol And Lescol Xl Are Indicated To: Reduce The Risk Of Undergoing Coronary Revascularization Procedures Slow The Progression Of Coronary Atherosclerosis 1.3 Limitations Of Use Neither Lescol Nor Lescol Xl Have Been Studied In Conditions Where The Major Abnormality Is Elevation Of Chylomicrons, Vldl, Or Idl (i.e., Hyperlipoproteinemia Types I, Iii, Iv, Or V).

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Butylparaben BUTYLPARABEN Molecular
3. Carboxymethylcellulose Sodium, Unspecified Form CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Unresolved
4. Edetate Calcium Disodium EDETATE CALCIUM DISODIUM Molecular
5. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
6. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
7. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
8. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluvastatin Sodium FLUVASTATIN SODIUM ZINC3830863

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