NIACOR
Details
- Status
- Prescription
- First Approved
- 2000-05-03
- Routes
- ORAL
- Dosage Forms
- TABLET
NIACOR Approval History
What NIACOR Treats
4 indicationsNIACOR is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atherosclerotic Vascular Disease
- Hypercholesterolemia
- Hyperlipidemia
- Pancreatitis
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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.
NIACOR FDA Label Details
ProIndications & Usage
FDA Label (PDF)I. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types IIa and IIb) โ , when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (se...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.