COLESTIPOL HYDROCHLORIDE · IMPAX LABS
INDICATIONS & USAGE Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.
Details
- Status
- Prescription
- First Approved
- 1977-04-04
- Routes
- ORAL
- Dosage Forms
- TABLET, GRANULE
COLESTIPOL HYDROCHLORIDE Approval History
What COLESTIPOL HYDROCHLORIDE Treats
2 indicationsCOLESTIPOL HYDROCHLORIDE is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercholesterolemia
- Atherosclerotic Vascular Disease
COLESTIPOL HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to COLESTIPOL HYDROCHLORIDE
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
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.
COLESTIPOL HYDROCHLORIDE FDA Label Details
Indications & Usage
INDICATIONS & USAGE Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. Therapy ...
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COLESTID
Full clinical data, patents, trials, and competitive landscape for colestipol hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.