Overview
Fluvastatin is an antilipemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonic acid, the rate-limiting step in cholesterol biosynthesis. Fluvastatin belongs to a class of medications called statins and is used to reduce plasma cholesterol levels and prevent cardiovascular disease. It is also the first entirely synthetic HMG-CoA reductase inhibitor and is structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin is a racemate comprising equimolar amounts of (3R,5S)- and (3S,5R)-fluvastatin.
Background
Fluvastatin is an antilipemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonic acid, the rate-limiting step in cholesterol biosynthesis. Fluvastatin belongs to a class of medications called statins and is used to reduce plasma cholesterol levels and prevent cardiovascular disease. It is also the first entirely synthetic HMG-CoA reductase inhibitor and is structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin is a racemate comprising equimolar amounts of (3R,5S)- and (3S,5R)-fluvastatin.
Indication
To be used as an adjunct to dietary therapy to prevent cardiovascular events. May be used as secondary prevention in patients with coronary heart disease (CHD) to reduce the risk of requiring coronary revascularization procedures, for reducing progression of coronary atherosclerosis in hypercholesterolemic patients with CHD, and for the treatment of primary hypercholesterolemia and mixed dyslidipidemia.
Associated Conditions
- Atherosclerosis
- Heterozygous Familial Hypercholesterolemia (HeFH)
- Mixed Dyslipidemias
- Primary Hypercholesterolemia
- Revascularization procedures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/26 | Early Phase 1 | Withdrawn | |||
2019/07/23 | Phase 4 | Completed | |||
2018/04/27 | Phase 3 | Completed | |||
2018/04/27 | Phase 3 | Completed | |||
2018/01/08 | Not Applicable | Completed | |||
2017/06/16 | Phase 4 | Completed | |||
2015/08/07 | N/A | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | ||
2015/08/07 | N/A | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | ||
2014/04/15 | Phase 1 | Completed | |||
2013/11/25 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Carilion Materials Management | 68151-4471 | ORAL | 80 mg in 1 1 | 3/1/2012 | |
| Bryant Ranch Prepack | 63629-8812 | ORAL | 20 mg in 1 1 | 8/31/2020 | |
| Physicians Total Care, Inc. | 54868-4224 | ORAL | 40 mg in 1 1 | 3/23/2011 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7446 | ORAL | 80 mg in 1 1 | 10/7/2022 | |
| Carilion Materials Management | 68151-1326 | ORAL | 20 mg in 1 1 | 1/25/2013 | |
| Mylan Pharmaceuticals Inc. | 0378-8021 | ORAL | 40 mg in 1 1 | 8/20/2020 | |
| Physicians Total Care, Inc. | 54868-4601 | ORAL | 80 mg in 1 1 | 3/23/2011 | |
| Physicians Total Care, Inc. | 54868-3329 | ORAL | 20 mg in 1 1 | 3/23/2011 | |
| Carilion Materials Management | 68151-1334 | ORAL | 40 mg in 1 1 | 1/25/2013 | |
| Novartis Pharmaceuticals Corporation | 0078-0354 | ORAL | 80 mg in 1 1 | 11/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fluvastatin Sodium Extended Release Tablets | 国药准字H20234643 | 化学药品 | 片剂 | 12/13/2023 | |
| Fluvastatin Sodium Extended Release Tablets | 国药准字H20213801 | 化学药品 | 片剂 | 10/26/2021 | |
| Fluvastatin Sodium Extended Release Tablets | 国药准字H20090179 | 化学药品 | 片剂 | 10/19/2023 | |
| Fluvastatin Sodium Capsules | 国药准字H20070167 | 化学药品 | 胶囊剂 | 10/22/2021 | |
| Fluvastatin Sodium Capsules | 国药准字H20010517 | 化学药品 | 胶囊剂 | 12/26/2019 | |
| Fluvastatin Sodium Capsules | 国药准字H20070168 | 化学药品 | 胶囊剂 | 10/22/2021 | |
| Fluvastatin Sodium Capsules | 国药准字H20010518 | 化学药品 | 胶囊剂 | 8/22/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LESCOL XL fluvastatin 80mg tablet blister pack | 82743 | Medicine | A | 9/17/2002 |