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POZEN Inc's PA8140/PA32540 receives complete response letter from FDA citing issues at facility of third party supplier of an active ingredient


Friday, 25 Apr 2014 08:30pm EDT 

POZEN Inc:Says that their drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA).A CRL is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA) in its current form.In the CRL, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier that concluded this week, inspection deficiencies were found.Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved.POZEN believes that these manufacturing facility items can be addressed and will be working with the manufacturer to respond to the FDA as soon as possible.There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the CRL.Final agreement on the draft product labeling is also pending. 

Company Quote

9.0
0.03 +0.33%
26 Nov 2014