Ranbaxy Laboratories Limited (Ranbaxy), has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Pravastatin Sodium Tablets, 10 mg, 20 mg, 40 mg, and 80 mg. Annual sales for the Pravastatin Tablet market are $1.8 billion, stated a company release.

Pravastatin Sodium Tablets are indicated in the treatment of primary prevention of coronary events such as in hypercholesterolemic patients without clinically evident coronary heart disease. It is indicated to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures and reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. It is also prescribed for treatment in the secondary prevention of cardiovascular events such as in patients with clinically evident coronary heart disease to reduce the risk of total mortality by reducing coronary death, reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures, reduce the risk of stroke and stroke/transient ischemic attack (TIA), and slow the progression of coronary atherosclerosis.

Pravastatin Sodium is also used in treating hyperlipidemia as an adjunct to diet to reduce elevated Total-C, LDL-C, Apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). The product is also indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV) and for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Commenting on the development, Jim Meehan, Vice President, Sales and Marketing, Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, said, "This places RPI in a position to offer products to the U.S. healthcare system with a proven clinical record in the management of hyperlipidemia. Recently, we received tentative approval for Simvastatin, and now Pravastatin, which will be offered as an affordable generic alternative that will have a measurable effect on the economics of healthcare. The product will be made available by RPI under the Ranbaxy label through wholesalers, distributors and pharmacies on a nationwide basis upon final approval."

Dipak Chattaraj, President of RPI, stated, "The approval of Pravastatin again demonstrates the capabilities of the Ranbaxy global organization to develop products from Active Pharmaceutical Ingredients to manufacturing of the finished dosage form that will be sold under the RPI label and be available to all dispensing outlets across the nation." Chattaraj further remarked,” This is another milestone since it represents the 20th ANDA approval granted to Ranbaxy thus far in 2003, the statement said.