Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to manufacture and market Pravastatin sodium tablets (Pravastatin), 10mg, 20mg, 40mg and 80mg, with 180 day market exclusivity in the US healthcare system for the 80 mg strength.
The Office of Generic Drugs, US 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. The annual sales for 80mg alone are $209 Mn, the company release stated.
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 US 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 US healthcare system.