FDAnews Drug Daily Bulletin

NOVARTIS GETS MARKETING APPROVAL FOR NEW LOTREL STRENGTHS

June 20, 2006
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Novartis has received marketing approval from the FDA for two new dosing strengths of its hypertension drug Lotrel in 5/40 mg and 10/40 mg. The new strengths, which will be made available this month, combine the calcium channel blocker amlodipine with the highest-available dose of the angiotensin converting enzyme (ACE)-inhibitor benazepril.

The new dosages "offer physicians powerful new options to manage high blood pressure effectively, conveniently and efficiently with the highest available dose of an ACE inhibitor," said Marjorie Gatlin, vice president of clinical development and medical affairs at Novartis.