Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has received tentative approval from the Food and Drug Administration to market Benazepril Hydrochloride Tablets in 5 mg, 10 mg, 20 mg and 40 mg strengths. The Division of Bio-equivalence has determined that the RPI formulation of Benazepril Hydrochloride Tablets is bio-equivalent to the listed drug Lotensin of Novartis Pharmaceuticals Corporation. In 2002, sales of this dosage form totaled $332.5 million (IMS - MAT, December, 2002).

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.

According to Dipak Chattaraj, President of RPI, "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. This product reflects the scientific/technical capabilities within RLL, our parent organization that developed the product from API to the finished dosage form that will be manufactured by Ohm Laboratories (Ohm), located in North Brunswick, New Jersey. This is an achievement that distinguishes Ranbaxy from other companies and provides a level of confidence as to the reliability of supply of this product in the future." Product availability of all strengths will be based on final FDA approval being granted.