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Data updated: Mar 10, 2026

NIACOR

NIACIN
Cardiovascular Approved 2000-05-03
1
Indication
--
Phase 3 Trials
25
Years on Market

Details

Status
Prescription
First Approved
2000-05-03
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: NIACIN

NIACOR Approval History

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What NIACOR Treats

4 indications

NIACOR 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
Source: FDA Label

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Active Pipeline

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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

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.

NIACOR FDA Label Details

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Indications & 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.