US FDA approves Ranbaxy's sale of furosemide in the US
The Office of Generic
21 September 2006
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.