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Research Report
Pitavastatin (Livalo): A Comprehensive Pharmacological and Clinical Review with Focus on Veterans Affairs Considerations
1. Introduction to Pitavastatin (Livalo / LivaloVA)
1.1. Pharmacological Class and Overview
Pitavastatin, marketed under the brand name Livalo, is a synthetic lipid-lowering agent belonging to the class of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, commonly known as statins.[1] Its primary therapeutic application is the management of dyslipidemia, specifically to reduce elevated levels of cholesterol and other atherogenic lipids in the bloodstream, thereby contributing to the reduction of cardiovascular disease risk.[1] Pitavastatin was developed by Kowa Company, Ltd., a Japanese pharmaceutical company, and is marketed in the United States by its subsidiary, Kowa Pharmaceuticals America, Inc..[4] Statins, as a class, represent a cornerstone in the primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD), and understanding the specific pharmacological and clinical profile of individual agents like pitavastatin is essential for optimizing patient care.
1.2. Contextualizing "LivaloVA" (Pitavastatin and VA Relevance)
The designation "LivaloVA" in the context of this report refers to Livalo (pitavastatin) as it pertains to the U.S. Department of Veterans Affairs (VA) healthcare system. A critical aspect of its status within this system is that Livalo (pitavastatin) is currently classified as "NF Non-Formulary" on the VA National Formulary.[6] This non-formulary status signifies that its prescription and dispensation within VA facilities require a specific non-formulary drug request and prior approval, with a general preference for formulary alternatives when clinically appropriate.[6] For veterans who do receive pitavastatin through the VA system, it falls under Copay Tier 2, as of November 9, 2023.[6]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/04/28 | Phase 1 | Completed | JW Pharmaceutical | ||
2022/04/15 | Phase 3 | Completed | JW Pharmaceutical |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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