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Saturday, April 26, 2014 2:44:44 AM
http://ih.advfn.com/p.php?pid=nmona&article=61973188
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.
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