Ranbaxy Receives Approval to Commercialize Generic Furosemide Tablets in the U.S.

The Office of Generic Drugs, FDA, granted Ranbaxy Laboratories (RLL) approval to manufacture and market its generic version of Aventis Pharmaceuticals’ Lasix®. Ranbaxy Laboratories’ Furosemide tablets USP, 20 mg, 40 mg, and 80 mg were found to be bioequivalent and have the same therapeutic effect as that of Lasix tablets, 20 mg, 40 mg, and 80 mg, respectively, which is the reference listed drug.

“This approval represents an opportunity for RPI to introduce another affordable generic alternative,” according to Jim Meehan, vp, U.S. sales and marketing for Ranbaxy Pharmaceuticals (RPI), wholly owned subsidiary of India-based RLL. RPI handles the sale and distribution of generic and branded prescription products in the U.S.

Total annual market sales for Furosemide tablets were $70 million. Furosemide is indicated in adults, infants, and children for edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is also a potent diuretic and thus particularly useful when an agent with greater diuretic potential is desired. Also, Furosemide may be used in adults for hypertension, alone or in combination with other antihypertensive agents.

“This approval is the result of a strategic alliance with Ipca Laboratories of Mumbai, India,” says Meehan.