Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration to manufacture and market Furosemide tablets USP, 20 mg, 40 mg, and 80 mg. the office of generic drugs, US 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.
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 US 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 US in the future, following US FDA approval," according to Jim Meehan, Vice President, U.S. Sales and Marketing for RPI.