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.
Background
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 |
|---|---|---|---|---|---|
2014/06/06 | 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 | |||
2012/12/19 | Not Applicable | 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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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fenofibrate Tablets | 国药准字H61020632 | 化学药品 | 片剂 | 6/17/2020 | |
| Fenofibrate Tablets | 国药准字H45020314 | 化学药品 | 片剂 | 9/1/2020 | |
| Fenofibrate Tablets | 国药准字H23020134 | 化学药品 | 片剂(素片) | 6/21/2020 | |
| Fenofibrate Tablets | 国药准字H13022441 | 化学药品 | 片剂 | 10/18/2020 | |
| Fenofibrate Tablets | 国药准字H44024996 | 化学药品 | 片剂 | 2/11/2020 | |
| Fenofibrate Tablets | 国药准字H21022102 | 化学药品 | 片剂 | 5/12/2020 | |
| Fenofibrate Tablets | 国药准字H13023043 | 化学药品 | 片剂 | 10/12/2020 | |
| Fenofibrate Tablets | 国药准字H15020900 | 化学药品 | 片剂 | 3/25/2020 | |
| Fenofibrate Tablets | 国药准字H32025106 | 化学药品 | 片剂 | 6/22/2020 | |
| Fenofibrate Tablets | 国药准字H20033275 | 化学药品 | 片剂 | 2/8/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||