Ranbaxy Granted Final Usfda Approval To Manufacture And Market Atenolol Tablets
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- Published on Wednesday, 03 January 2007 02:00
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GURGAON, India | Jan 02, 2007 | Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. 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 Tenormin® of AstraZeneca LP. Total annual market sales for Atenolol were $133.6 million (IMS – MAT: September 2006).
Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Atenolol is also indicated for the long-term management of patients with angina pectoris due to coronary atherosclerosis and is also indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.
“We are pleased to receive this final FDA approval to market Atenolol tablets. This will further expand our product portfolio of affordable generic alternatives to the brand in the treatment of cardiovascular disorders. This approval is the result of a strategic alliance with Ipca Laboratories Ltd. of Mumbai, India, who will develop a number of generic prescription pharmaceutical products which will be marketed by RPI in the U.S. in the future following U.S. FDA approval. RPI labeled Atenolol tablets will be made available to our customers in the U.S. healthcare system during first quarter 2007,” according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
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 9 countries.
*Tenormin® is a registered trademark of AstraZeneca