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Novartis wins FDA approval for new Lotrel doses

Novartis has received marketing approval from the FDA for two new dosing strengths of its antihypertensive Lotrel.

The new dosing strengths, 5/40mg and 10/40mg, combine the calcium channel blocker (CCB) amlodipine with the highest available dose of the ACE inhibitor benazepril.

According to Novartis, Lotrel has the broadest marketed dosing range of any CCB and ACE inhibitor combination. The drug is one of the fastest growing branded antihypertensives on the market with sales exceeding a billion dollars in 2005.

The addition of the new higher strengths provides physicians with expanded dosing flexibility and offers two additional treatment options for previously uncontrolled patients who need blood pressure lowering with the benefits of the higher dose ACE inhibitor.

“Lotrel 5/40 mg and 10/40 mg offer physicians’ powerful new options to manage high blood pressure effectively, conveniently and efficiently with the highest available dose of an ACE inhibitor,” said Dr Marjorie Gatlin, vice president CVM, Novartis Pharmaceuticals Corporation.