The US Food and Drug Administration has granted Israel's Tevatentative approval for benazepril hydrochloride tablets, 5mg, 10mg, 20mg and 40mg. The tablets are the AB-rated generic equivalent of Novartis' Lotensin, which has annual sales of about $333 million. Final approval is anticipated upon expiry of pediatric exclusivity, which protects the brand product until February 11, 2004. India's Ranbaxy has also been granted tentative approval to sell generic Lotensin.
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