7:30AM POZEN submits new drug application for PA32540/PA8140 (POZN) 5.24 : Co announced the submission of a New Drug Application to the FDA for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole, a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
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