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Ranbaxy receives approval to commercialize Furosemide tablets in the US |
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21 Sep 2006 |
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg
GURGAON, India | Sep 21, 2006 | Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Furosemide Tablets USP, 20 mg, 40 mg, and 80 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 Lasix® Tablets, 20 mg, 40 mg, and 80 mg, respectively, of Aventis Pharmaceuticals Inc. Total annual market sales for Furosemide Tablets were $70 million (IMS – MAT: June 2006).
Furosemide is indicated in adults, infants, and children for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Also, Furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
“This approval represents an opportunity for RPI to introduce another affordable generic alternative and further increase our ever-growing product portfolio to meet the needs of our customers as well as patients and prescribers in the U.S. healthcare system. This approval is the result 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 US FDA approval.,” according to Jim Meehan, Vice President, U.S. Sales and Marketing 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 8 countries.
Lasix ® is a registered trademark of Aventis Pharmaceuticals Inc.
SOURCE: Ranbaxy Laboratories Limited |
