Pozen, Inc. (POZN) Resubmits PA8140/PA32540 NDA
7/2/2014 9:52:55 AM
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it has resubmitted the New Drug Application (NDA) for PA8140/PA32540 to the U.S. Food and Drug Administration (FDA). In accordance with the regulations, FDA is expected to notify POZEN within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review is necessary. Issues raised during an audit of the manufacturing facility producing an active ingredient used in the manufacture of the products were the only deficiencies noted in the Complete Response Letter (CRL) POZEN received on April 25, 2014. Final agreement on the draft product labeling is also pending.
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