7:30AM POZEN announces FDA acceptance of filing of New Drug Application for PA32540/PA8140 tablets (POZN) 5.22 : Co announced that the FDA has accepted for review, the New Drug Application (NDA) for PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA also indicated the review classification is Standard; therefore, the user fee goal date is January 24, 2014. Pending FDA review and approval, an indication is sought for PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
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