Ranbaxy receives US FDA approval to manufacture & market Pravastatin Sodium Tablets in USA

Ranbaxy Laboratories Ltd on April 25, 2007 has announced that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Pravastatin Sodium Tablets (Pravastatin), 10 mg, 20 mg, 40 mg and 80 mg, with 180 day market exclusivity in the U.S. healthcare system for the 80 mg strength. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Company's formulation to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Pravachol® by Bristol Myers Squibb. Total annual market sales for all strengths were $ 1.19 billion (IMS - MAT: December 2006). The annual sales for 80mg alone is $ 209 Mn (IMS: MAT - Dec. 2006).

Pravastatin is indicated in the treatment of primary prevention of coronary events such as in hypercholesterolemic patients without clinically evident coronary heart disease. Pravastatin is also 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 indicated for treatment in the secondary prevention of cardiovascular events such as in patients with clinically evident coronary heart disease to reduce the risk of stroke and stroke / transient ischemic attack (TIA), and slow the progression of coronary atherosclerosis.

"Ranbaxy is pleased to now offer Pravastatin as an affordable generic alternative that will have a measurable impact on the U.S. healthcare system. Pravastatin 80 mg tablets will be made available for 180 days on an exclusive basis under the Ranbaxy label. Product will be manufactured at Ohm Laboratories in New Brunswick, New Jersey and will be made available through wholesalers, distributors and pharmacies on a nationwide basis, according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company, India largest pharmaceutical Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Source : Equity Bulls

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