Pozen submits combined NDA for PA32540, PA8140

Pozen Inc. (NASDAQ:POZN) submitted a combined NDA to FDA for PA32540 and PA8140 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The products are tablets comprising low- or high-dose aspirin and an immediate-release coating of 40 mg omeprazole, a proton pump inhibitor (PPI). PA32540 contains 325 mg aspirin, while PA8140 comprises 81 mg aspirin. Pozen had previously planned to submit an application in 3Q12 for PA32540 only, but FDA suggested last May that the application should include PA8140. ...