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Data updated: Mar 10, 2026

PREVALITE

CHOLESTYRAMINE Bile-acid Binding Activity
Cardiovascular Approved 1996-02-22
1
Indication
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1996-02-22
Routes
ORAL
Dosage Forms
POWDER

Companies

Active Ingredient: CHOLESTYRAMINE

PREVALITE Approval History

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What PREVALITE Treats

3 indications

PREVALITE is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypercholesterolemia
  • Hypertriglyceridemia
  • Atherosclerotic Vascular Disease
Source: FDA Label

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Trial Timeline

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.

PREVALITE FDA Label Details

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Indications & Usage

1) Prevalite ® (cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ® (cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple ris...

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Data Sources

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