Data updated: Mar 10, 2026
FENOFIBRATE
FENOFIBRATE
Approved 2005-05-13
31
Indications
--
Phase 3 Trials
20
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2005-05-13
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Viatris BOSTAL ALEMBIC Sun Pharma Lupin AMNEAL RHODES PHARMS BAUSCH RISING Aurobindo Pharma Cipla AJANTA PHARMA LTD MACLEODS PHARMS LTD YICHANG HUMANWELL HETERO LABS LTD III IMPAX LABS CHARTWELL RX PRINSTON INC Dr. Reddy's CREEKWOOD PHARMS MANKIND PHARMA
Active Ingredient: FENOFIBRATE
Website: ↗
FENOFIBRATE Approval History
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What FENOFIBRATE Treats
31 FDA approvalsOriginally approved for its first indication in 2005 . Covers 31 distinct patient populations.
- Other (31)
Other
(31 approvals)- • Approved indication (May 2005)
- • Approved indication (Oct 2005)Letter
- • Approved indication (Dec 2005)
- • Approved indication (Mar 2008)
- • Approved indication (Dec 2011)Letter
- • Approved indication (Apr 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Aug 2015)
- • Approved indication (May 2016)
- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Jul 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Sep 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Feb 2018)
- • Approved indication (Mar 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Mar 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Feb 2021)
- • Approved indication (Sep 2022)
- • Approved indication (Sep 2023)
- • Approved indication (Apr 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Jan 2026) New
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
FENOFIBRATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.