What is CLOFIBRATE used for?

CLOFIBRATE is an FDA-approved medication. See full prescribing information for approved uses.

Is CLOFIBRATE FDA approved?

Yes, CLOFIBRATE is FDA approved (first approved 1986-06-16) and manufactured by Novartis.

Who makes CLOFIBRATE?

CLOFIBRATE is manufactured by Novartis.

Data updated: Mar 10, 2026

CLOFIBRATE

Approved 1986-06-16

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1986-06-16
Routes: ORAL
Dosage Forms: CAPSULE

Companies

Novartis USL PHARMA Teva WATSON LABS BANNER PHARMACAPS

Active Ingredient: CLOFIBRATE

CLOFIBRATE Approval History

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What CLOFIBRATE Treats

4 FDA approvals

Originally approved for its first indication in 1986 . Covers 4 distinct patient populations.

Other (4)

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Active Pipeline

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Ongoing clinical trials by development phase

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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

ClinicalTrials.gov ↗ Pro

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.

CLOFIBRATE FDA Label Details

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Data Sources

FDA Approval: ANDA072191 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.