Ranbaxy gets U.S. approval for hypertension drug

Tuesday, 04 March 2003, 20:30 IST
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NEW DELHI: Indian pharmaceutical major Ranbaxy Laboratories Limited (RLL) Monday announced that its wholly owned U.S.-based subsidiary has received tentative approval to market hypertension drug Benazepril Hydrochloride. Ranbaxy Pharmaceuticals Inc. (RPI) has got tentative approval from the U.S. Food and Drug Administration to market Benazepril Hydrochloride tablets in 5 mg, 10 mg, 20 mg and 40 mg strengths, a company statement said. "The division of bio-equivalence has determined that the RPI formulation of Benazepril Hydrochloride tablets is bio-equivalent to the listed drug Lotensin(r) of Novartis Pharmaceuticals Corporation." In 2002, sales of this dosage form totalled $332.5 million. Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. "In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, Captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Benazepril Hydrochloride tablets does not have a similar risk," the statement said. According RPI president Dipak Chattaraj, "this product will further expand the overall product portfolio and add breadth and depth to the number of cardiovascular products offered by Ranbaxy to the U.S. healthcare system."
Source: IANS
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