Overview
Pravastatin is the 6-alpha-hydroxy acid form of mevastatin. Pravastatin was firstly approved in 1991 becoming the second available statin in the United States. It was the first statin administered as the active form and not as a prodrug. This drug was developed by Sankyo Co. Ltd.; however, the first approved pravastatin product was developed by Bristol Myers Squibb and FDA approved in 1991. Pravastatin is made through a fermentation process in which mevastatin is first obtained. The manufacturing process is followed by the hydrolysis of the lactone group and the biological hydroxylation with Streptomyces carbophilus to introduce the allylic 6-alcohol group.
Background
Pravastatin is the 6-alpha-hydroxy acid form of mevastatin. Pravastatin was firstly approved in 1991 becoming the second available statin in the United States. It was the first statin administered as the active form and not as a prodrug. This drug was developed by Sankyo Co. Ltd.; however, the first approved pravastatin product was developed by Bristol Myers Squibb and FDA approved in 1991. Pravastatin is made through a fermentation process in which mevastatin is first obtained. The manufacturing process is followed by the hydrolysis of the lactone group and the biological hydroxylation with Streptomyces carbophilus to introduce the allylic 6-alcohol group.
Indication
Pravastatin is indicated for primary prevention of coronary events hypercholesterolemic patients without clinical evidence of coronary heart disease. Its use includes the reduction of risk on myocardial infarction, undergoing myocardial revascularization procedures and cardiovascular mortality. As well, pravastatin can be used as a secondary prevention agent for cardiovascular events in patients with clinically evident coronary heart disease. This indication includes the reduction of risk of total mortality by reducing coronary death, myocardial infarction, undergoing myocardial revascularization procedures, stroke, and stroke/transient ischemic attack as well as to slow the progression of coronary atherosclerosis. The term cardiovascular events correspond to all the incidents that can produce damage to the heart muscle including the interruption of blood flow. As adjunctive therapy to diet, pravastatin is used in: In patients that do not respond adequately to diet, pravastatin is used to treat patients with primary dysbetalipoproteinemia (type III hyperlipidemia). Dyslipidemia is defined as an elevation of plasma cholesterol, triglycerides or both as well as to the presence of low levels of high-density lipoprotein. This condition represents an increased risk for the development of atherosclerosis.
Associated Conditions
- Acute Coronary Events
- Cardiovascular Outcomes
- Coronary Artery Atherosclerosis
- Death
- Dysbetalipoproteinemia
- Heterozygous Familial Hypercholesterolemia (HeFH)
- High Cholesterol
- Hyperlipidemias
- Mixed Dyslipidemias
- Myocardial Infarction
- Myocardial Revascularization
- Secondary prevention cardiovascular event
- Stroke
- Sudden Cardiac Death
- Transient Ischemic Attack
- Elevation of serum triglyceride levels
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/06 | Phase 2 | Not yet recruiting | |||
2024/07/10 | Phase 2 | Not yet recruiting | |||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. | ||
2024/03/22 | Phase 1 | Recruiting | Children's Mercy Hospital Kansas City | ||
2023/05/10 | Phase 1 | Completed | |||
2022/09/01 | Phase 1 | Completed | |||
2021/11/15 | N/A | Active, not recruiting | |||
2021/11/04 | N/A | Completed | |||
2021/01/22 | Phase 4 | UNKNOWN | |||
2020/11/23 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
PD-Rx Pharmaceuticals, Inc. | 43063-443 | ORAL | 20 mg in 1 1 | 2/24/2023 | |
Bryant Ranch Prepack | 63629-9162 | ORAL | 10 mg in 1 1 | 7/26/2021 | |
Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-236 | ORAL | 40 mg in 1 1 | 1/4/2021 | |
Bryant Ranch Prepack | 63629-8904 | ORAL | 10 mg in 1 1 | 7/26/2021 | |
Quallent | 82009-006 | ORAL | 20 mg in 1 1 | 12/5/2023 | |
Lupin Pharmaceuticals, Inc. | 68180-485 | ORAL | 10 mg in 1 1 | 12/19/2023 | |
DirectRX | 61919-731 | ORAL | 20 mg in 1 1 | 1/21/2020 | |
Bryant Ranch Prepack | 63629-9164 | ORAL | 40 mg in 1 1 | 7/26/2021 | |
Quallent | 82009-007 | ORAL | 40 mg in 1 1 | 12/5/2023 | |
Direct_Rx | 61919-734 | ORAL | 80 mg in 1 1 | 1/15/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/14/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
PRAVAFEN HARD CAPSULES 40mg/160mg | SIN14508P | CAPSULE | 40mg | 2/21/2014 | |
APO-PRAVASTATIN TABLET 20 mg | SIN12670P | TABLET | 20 mg | 7/22/2005 | |
APO-PRAVASTATIN TABLET 10 mg | SIN12671P | TABLET | 10 mg | 7/22/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Pravastatin Sodium Capsules | 国药准字H20080673 | 化学药品 | 胶囊剂 | 9/8/2023 | |
Pravastatin Sodium Capsules | 国药准字H20080674 | 化学药品 | 胶囊剂 | 6/14/2023 | |
Pravastatin Sodium Tablets | 国药准字H20253858 | 化学药品 | 片剂 | 4/8/2025 | |
Pravastatin Sodium Tablets | 国药准字H20040100 | 化学药品 | 片剂 | 12/17/2019 | |
Pravastatin Sodium Tablets | 国药准字H20050736 | 化学药品 | 片剂 | 7/8/2020 | |
Pravastatin Sodium Tablets | 国药准字H20253951 | 化学药品 | 片剂 | 4/15/2025 | |
Pravastatin Sodium Tablets | 国药准字H20253952 | 化学药品 | 片剂 | 4/15/2025 | |
Pravastatin Sodium Tablets | 国药准字H20234727 | 化学药品 | 片剂 | 12/29/2023 | |
Pravastatin Sodium Tablets | 国药准字H20050150 | 化学药品 | 片剂 | 5/22/2020 | |
Pravastatin Sodium Tablets | 国药准字H20234726 | 化学药品 | 片剂 | 12/29/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PMS-PRAVASTATIN TAB 20MG | N/A | trenton-boma ltd | N/A | N/A | 11/2/2004 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PRALECT 10 pravastatin sodium 10mg tablet bottle | 191715 | Medicine | A | 10/24/2012 | |
PRAVASTATIN AN pravastatin sodium 20mg tablet bottle | 191716 | Medicine | A | 10/24/2012 | |
APX-PRAVASTATIN pravastatin sodium 20 mg tablet blister pack | 335751 | Medicine | A | 6/23/2020 | |
AURO-PRAVASTATIN 20 pravastatin sodium 20mg tablet bottle | 191699 | Medicine | A | 10/24/2012 | |
PRAVASTATIN AN pravastatin sodium 40mg tablet bottle | 191702 | Medicine | A | 10/24/2012 | |
APO-PRAVASTATIN pravastatin sodium 10 mg tablets bottle | 166255 | Medicine | A | 1/11/2010 | |
PRAVASTATIN AN pravastatin sodium 80mg tablet bottle | 191694 | Medicine | A | 10/24/2012 | |
PRALECT 10 pravastatin sodium 10mg tablet blister pack | 191703 | Medicine | A | 10/24/2012 | |
PRAVASTATIN SANDOZ pravastatin sodium 20 mg tablet blister pack | 152458 | Medicine | A | 10/12/2009 | |
PRALECT 80 pravastatin sodium 80mg tablet blister pack | 191711 | Medicine | A | 10/24/2012 |