Ranbaxy receives us FDA approval to manufacture and market Pravastatin Sodium Tablets in USA
Ranbaxy granted 180 days exclusivity for 80mg dosage
Tweet-- Ranbaxy Laboratories Limited (RLL), announced today 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 Ranbaxy 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.
Notes to Editor
About Ranbaxy Pharmaceuticals
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
About Ranbaxy Laboratories
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 9 countries.
For more information, visit www.ranbaxy.com.