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POZEN Inc announces FDA acceptance of refiling of new drug application for PA8140/PA32540 Tablets


Wednesday, 16 Jul 2014 07:30am EDT 

POZEN Inc:Says U.S. Food and Drug Administration (FDA) has accepted for review, resubmission of the New Drug Application (NDA) for PA8140/PA32540.Says FDA also indicated NDA would be treated as a Class 2 resubmission, therefore, the new user fee goal date is Dec. 30.Says issues raised during an audit of the manufacturing facility producing an active ingredient used in manufacture of products were the only deficiencies noted in Complete Response Letter (CRL) POZEN received on April 25.Says if such inspection deficiencies are not satisfactorily addressed by the new user fee goal date, the FDA could issue another CRL. POZEN has agreed substantively to FDA's most recent draft product labeling. 

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24 Apr 2015