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Pozen, Inc. (POZN) Announces New PA8140/PA32540 PDUFA Date Of April 25, 2014


12/23/2013 9:21:43 AM

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CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ:POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that following ongoing interactions with the United States Food & Drug Administration (FDA) concerning its New Drug Application (NDA) for PA8140/PA32540 tablets, the Company has decided to conduct a comparative Phase 1 pharmacokinetic study. The goal of the study is to determine the pharmacokinetic profile of the omeprazole component of PA8140 tablets and compare it to that of PA32540 tablets. Both PA dosage forms contain 40 mg of omeprazole in an immediate release form and are manufactured using nearly identical procedures.

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