FLUVASTATIN SODIUM · PHARMOBEDIENT
Fluvastatin sodium is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and in adults and pediatric patients (aged 10 and older) with heterozygous familial hypercholesterolemia. In patients with clinically evident coronary heart disease, it is used to slow the progression of coronary atherosclerosis and reduce the risk of undergoing coronary revascularization procedures.
How FLUVASTATIN SODIUM Works
Fluvastatin is a competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol. By inhibiting this pathway, it reduces endogenous cholesterol synthesis.
Details
- Status
- Prescription
- First Approved
- 1993-12-31
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, CAPSULE
FLUVASTATIN SODIUM Approval History
What FLUVASTATIN SODIUM Treats
4 indicationsFLUVASTATIN SODIUM is approved for 4 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Heart Disease
- Coronary Atherosclerosis
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
FLUVASTATIN SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01551173 results posted | CXUO320BCN01 | Ph 4 | completed | Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
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.
FLUVASTATIN SODIUM FDA Label Details
Indications & Usage
Fluvastatin sodium extended-release tablets are indicated: To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily. Fluvastatin sodium extended-release tablets are indi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.