Overview
Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia. Fenofibrate was granted FDA approval on 31 December 1993.
Indication
Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia.
Associated Conditions
- Mixed Dyslipidemias
- Primary Hypercholesterolemia
- Severe Hypertriglyceridemia (sHTG)
- Severe Fredrickson Type IV Hypertriglyceridemia
- Severe Fredrickson Type V Hypertriglyceridemia
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/10/10 | Phase 3 | Completed | |||
2014/06/06 | Phase 2 | Completed | |||
2014/06/03 | Phase 4 | Completed | Institut Investigacio Sanitaria Pere Virgili | ||
2014/02/19 | Phase 1 | Completed | |||
2013/12/19 | Phase 4 | UNKNOWN | Koval' O., MD | ||
2013/10/18 | Phase 2 | Terminated | |||
2013/10/08 | Phase 3 | UNKNOWN | |||
2013/08/22 | Phase 4 | Completed | University of Padova | ||
2013/06/14 | Phase 3 | Completed | Zhejiang University | ||
2013/01/14 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Inc. | 62332-538 | ORAL | 54 mg in 1 1 | 11/26/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2587 | ORAL | 145 mg in 1 1 | 7/17/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-7101 | ORAL | 160 mg in 1 1 | 2/24/2021 | |
| Torrent Pharmaceuticals Limited | 13668-439 | ORAL | 134 mg in 1 1 | 8/1/2022 | |
| Shore Therapeutics, Inc | 52725-490 | ORAL | 40 mg in 1 1 | 11/15/2010 | |
| Mylan Pharmaceuticals Inc. | 0378-7100 | ORAL | 54 mg in 1 1 | 2/24/2021 | |
| Lupin Pharmaceuticals, Inc. | 68180-131 | ORAL | 130 mg in 1 1 | 11/2/2023 | |
| Aurobindo Pharma Limited | 59651-201 | ORAL | 67 mg in 1 1 | 9/8/2021 | |
| Proficient Rx LP | 63187-681 | ORAL | 160 mg in 1 1 | 12/1/2018 | |
| Golden State Medical Supply, Inc. | 51407-204 | ORAL | 48 mg in 1 1 | 9/6/2022 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
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PPB Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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