PRINCETON, N.J., Sept. 6 Ranbaxy Pharmaceuticals Inc.(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),announced today that RLL has received approval from the U.S. Food and DrugAdministration to manufacture and market Carvedilol Tablets, 3.125 mg, 6.25mg, 12.5, and 25 mg, a beta blocker used to treat heart failure. The Officeof Generic Drugs, U.S. Food and Drug Administration, has determined theRanbaxy formulations to be bioequivalent and have the same therapeutic effectas that of the reference listed drug Coreg(R) Tablets, 3.125 mg, 6.25 mg, 12.5mg, and 25 mg, respectively, of GlaxoSmithKline. Total annual market salesfor Carvedilol Tablets were $1.6 billion (IMS - MAT: June 2007).
Carvedilol is indicated for the treatment of mild-to-severe heart failureof ischemic or cardiomyopathic origin, usually in addition to diuretics, ACEinhibitor and digitalis. Carvedilol is also indicated to reducecardiovascular mortality in clinically stable patients who have survived theacute phase of a myocardial infarction, as well as in the management ofessential hypertension, alone or in combination with other antihypertensiveagents.
"We are pleased to receive this FDA approval for Carvedilol Tablets thatwill add depth and breadth to our product line of medications used incardiovascular diseases. This approval further represents yet anotherapproval in 2007, that expands our product portfolio of affordable genericalternatives. Carvedilol will be manufactured at our Ohm Laboratoriesfacility in New Brunswick, New Jersey and launched in to all classes of tradeearly in the fourth quarter of 2007 under the RPI label," noted Jim Meehan,Vice President of Sales and Distribution for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is awholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largestpharmaceutical company. RPI is engaged in the sale and distribution ofgeneric and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated,research based, international pharmaceutical company producing a wide range ofquality, affordable generic medicines, trusted by healthcare professionals andpatients across geographies. Ranbaxy's continued focus on R&D has resulted inseveral approvals in developed markets and significant progress in New DrugDiscovery Research. The Company's foray into Novel Drug Delivery Systems hasled to proprietary "platform technologies", resulting in a number of productsunder development. The Company is serving its customers in over 125 countriesand has an expanding international portfolio of affiliates, joint ventures andalliances, ground operations in 49 countries and manufacturing operations in11 countries.* Coreg(R) is a registered trademark of GlaxoSmithKline. CONTACTS: Charles M. Caprariello Vice President, Corporate Communications Ranbaxy Inc. (609) 720-5615 Edwige Buteau RF Binder Partners Inc. (212) 994-7517 Anuj Baveja RF Binder Partners Inc. (212) 994-7552
SOURCE Ranbaxy Pharmaceuticals Inc.