MedPath

Pravastatin

Generic Name
Pravastatin
Drug Type
Small Molecule
Chemical Formula
C23H36O7
CAS Number
81093-37-0
Unique Ingredient Identifier
KXO2KT9N0G

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

FDA Approved Products

PRAVASTATIN SODIUM
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:40 mg in 1 1
Approved: 2024/03/11
NDC:72162-1953
pravastatin sodium
Manufacturer:PD-Rx Pharmaceuticals, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/02/24
NDC:43063-443
PRAVASTATIN SODIUM
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:10 mg in 1 1
Approved: 2021/07/26
NDC:63629-8904
Pravastatin Sodium
Manufacturer:Northwind Pharmaceuticals, LLC
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/01/19
NDC:51655-070
Pravastatin Sodium
Manufacturer:State of Florida DOH Central Pharmacy
Route:ORAL
Strength:20 mg in 1 1
Approved: 2010/06/01
NDC:53808-0766

Singapore Approved Products

No Singapore products found for this drug

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