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FDA Accepts New Drug Application For Symplmed's Prestalia® For The Treatment Of Hypertension



6/17/2014 10:13:09 AM

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CINCINNATI--(BUSINESS WIRE)--Symplmed announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational drug Prestalia®, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA’s guidance. The Prescription Drug User Fee Act (PDUFA) goal date for Prestalia is January 21, 2015.

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