Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the company's ANDA for Benazepril Hydrochloride tablets, 5 mg, 10 mg, 20 mg and 40 mg. Final approval is anticipated upon expiry of pediatric exclusivity, which protects the brand product until February 11, 2004.
Benazepril Hydrochloride tablets are the AB-rated generic equivalent of Novartis' antihypertensive agent Lotensin tablets. Annual sales of the brand product are approximately $333 million.