Ranbaxy Gains Approval To Manufacture And Market Carvedilol Tablets In The U.S. Market

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Sep 2007 - 0:00 PDT

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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 Drug Administration to manufacture and market Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg, a beta blocker used to treat heart failure. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Coreg(R) Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, respectively, of GlaxoSmithKline. Total annual market sales for Carvedilol Tablets were $1.6 billion (IMS - MAT: June 2007).

Carvedilol is indicated for the treatment of mild-to-severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor and digitalis. Carvedilol is also indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction, as well as in the management of essential hypertension, alone or in combination with other antihypertensive agents.

"We are pleased to receive this FDA approval for Carvedilol Tablets that will add depth and breadth to our product line of medications used in cardiovascular diseases. This approval further represents yet another approval in 2007, that expands our product portfolio of affordable generic alternatives. Carvedilol will be manufactured at our Ohm Laboratories facility in New Brunswick, New Jersey and launched in to all classes of trade early 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 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.

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 11 countries.

Coreg(R) is a registered trademark of GlaxoSmithKline.

Ranbaxy Pharmaceuticals Inc.
http://www.ranbaxy.com