The US Food and Drug Administration has approved the sale of Indian drug major Ranbaxy Laboratories Ltd's furosemide tablets USP, 20mg, 40mg, and 80mg, developed through its manufacturing alliance with Mumbai's Ipca Laboratories
The Office of Generic Drugs, US FDA, 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, made by Aventis Pharmaceuticals Inc.
The 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.
Furosemide is also prescribed for the treatment of adult hypertension, either alone or in combination with other anti-hypertensive agents.
The company however cautions that hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
"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.," says Jim Meehan, vice president, US sales and marketing for RPI.
Through its wholly owned US subsidiary, Ranbaxy Pharmaceuticals Inc, Ranbaxy has an alliance with Mumbai-based Ipca Laboratories, which will develop prescription generic drugs to be marketed in the US by Ranbaxy.
Meehan added, "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."