Ranbaxy gets clearance from the US

Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL), has received tentative approval from the Food and Drug Administration (FDA), USA 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 totalled $332.5 million. The patent for this drug expires in August 2003. Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. RLL said that another angiotensin-converting enzyme inhibitor, Captopril, has been known to cause agranulocytosis.