PREVALITE
Details
- Status
- Prescription
- First Approved
- 1996-02-22
- Routes
- ORAL
- Dosage Forms
- POWDER
PREVALITE Approval History
What PREVALITE Treats
3 indicationsPREVALITE 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
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
ProIndications & 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.