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Daiichi submits Benicar/amlodipine combo

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Daiichi Sankyo submits an NDA Nov. 27 for a fixed-dose combination of its angiotensin receptor blocker Benicar (olmesartan) and the calcium channel blocker amlodipine, marketed by Pfizer as Norvasc. Pfizer's patent expires in September 2007; Daiichi is planning a fall 2007 launch of the combo, which could be used alone or in combination with other antihypertensive drugs. The firm reported that in clinical trials, the combination of amlodipine and olmesartan demonstrated a significant reduction in mean blood pressure...

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