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Data updated: Mar 10, 2026

EZETIMIBE AND SIMVASTATIN

EZETIMIBE Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiovascular Approved 2017-04-26
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-04-26
Routes
ORAL
Dosage Forms
TABLET

Companies

GLENMARK PHARMS LTD ALKEM LABS LTD TORRENT Dr. Reddy's WATSON LABS INC AMNEAL PHARMS CO Aurobindo Pharma ANI PHARMS SCIEGEN PHARMS
Active Ingredient: EZETIMIBE , SIMVASTATIN

EZETIMIBE AND SIMVASTATIN Approval History

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What EZETIMIBE AND SIMVASTATIN Treats

6 indications

EZETIMIBE AND SIMVASTATIN is approved for 6 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Atherosclerotic Vascular Disease
  • Hypercholesterolemia
  • Primary Hyperlipidemia
  • Mixed Hyperlipidemia
  • Homozygous Familial Hypercholesterolemia
  • Dyslipidemia
Source: FDA Label

Drugs Similar to EZETIMIBE AND SIMVASTATIN

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

LOVASTATIN
LOVASTATIN
3 shared
COREPHARMA
Shared indications:
DyslipidemiaAtherosclerotic Vascular DiseaseHypercholesterolemia
ZETIA
EZETIMIBE
3 shared
Merck
Shared indications:
Primary HyperlipidemiaMixed HyperlipidemiaHomozygous Familial Hypercholesterolemia
ATORVALIQ
ATORVASTATIN CALCIUM
2 shared
CMP DEV LLC
Shared indications:
Primary HyperlipidemiaHomozygous Familial Hypercholesterolemia
CHOLESTYRAMINE
CHOLESTYRAMINE
2 shared
PH HEALTH
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
CHOLESTYRAMINE LIGHT
CHOLESTYRAMINE
2 shared
PHARMOBEDIENT CNSLTG
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
COLESTID
COLESTIPOL HYDROCHLORIDE
2 shared
Pfizer
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
COLESTIPOL HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE
2 shared
ZYDUS PHARMS
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
FLOLIPID
SIMVASTATIN
2 shared
SALERNO PHARMS
Shared indications:
Primary HyperlipidemiaHomozygous Familial Hypercholesterolemia
LEQVIO
INCLISIRAN SODIUM
2 shared
Novartis
Shared indications:
HypercholesterolemiaHomozygous Familial Hypercholesterolemia
LIPITOR
ATORVASTATIN CALCIUM
2 shared
UPJOHN
Shared indications:
Primary HyperlipidemiaHomozygous Familial Hypercholesterolemia
LOCHOLEST
CHOLESTYRAMINE
2 shared
CHARTWELL RX
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
LOCHOLEST LIGHT
CHOLESTYRAMINE
2 shared
CHARTWELL RX
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
LYPQOZET
ATORVASTATIN CALCIUM
2 shared
PHARMOBEDIENT
Shared indications:
Primary HyperlipidemiaHomozygous Familial Hypercholesterolemia
NIACOR
NIACIN
2 shared
AVONDALE PHARMS
Shared indications:
Atherosclerotic Vascular DiseaseHypercholesterolemia
PREVALITE
CHOLESTYRAMINE
2 shared
AIPING PHARM INC
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
SIMVASTATIN
SIMVASTATIN
2 shared
RISING
Shared indications:
Primary HyperlipidemiaHomozygous Familial Hypercholesterolemia
CRESTOR
ROSUVASTATIN CALCIUM
1 shared
AstraZeneca
Shared indications:
Homozygous Familial Hypercholesterolemia
EVKEEZA
EVINACUMAB-DGNB
1 shared
Regeneron
Shared indications:
Homozygous Familial Hypercholesterolemia
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
1 shared
Teva
Shared indications:
Primary Hyperlipidemia
LEROCHOL
LERODALCIBEP-LIGA
1 shared
LIB THERAPEUTICS, INC.
Shared indications:
Hypercholesterolemia
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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov β†— Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

EZETIMIBE AND SIMVASTATIN FDA Label Details

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Indications & 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. Ezetimibe and simvastatin tablets, which contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), are indicated as adjunctive therapy to diet to: β€’ reduce elevated total-C,...

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Data Sources

FDA Approval: ANDA208699 β†’ Label: DailyMed β†’ Trials: ClinicalTrials.gov β†’

Data sourced from official FDA and NIH databases. Click links to verify on original sources.