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Novartis’ Exforge Has Late December User Fee Date

This article was originally published in The Pink Sheet Daily

Executive Summary

Novartis’ combination anti-hypertensive is already pending in the EU.

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Daiichi Sankyo Submits Benicar/Amlodipine Fixed-Dose Combination To FDA

Combination of olmesartan and amlodipine can be used alone or in conjunction with other antihypertensives, firm says.

Daiichi Sankyo Submits Benicar/Amlodipine Fixed-Dose Combination To FDA

Combination of olmesartan and amlodipine can be used alone or in conjunction with other antihypertensives, firm says.

Daiichi Sankyo Submits Benicar/Amlodipine Fixed-Dose Combination To FDA

Daiichi Sankyo submitted an NDA Nov. 27 for a fixed-dose combination of its angiotensin receptor blocker Benicar (olmesartan) and the calcium channel blocker amlodipine (currently marketed by Pfizer as Norvasc). The Japanese drug maker told "The Pink Sheet" DAILY it is seeking a standard review for treatment of hypertension

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