Pozen re-files for US approval of PA8140/PA32540
US drug firm Pozen (Nasdaq: POZN) has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole) delayed release tablets, to the US Food and Drug Administration.
The FDA, which earlier this year issued a complete response letter on the product, citing issues at a third party supplier of active ingredient, is expected to notify Pozen within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new Prescription Drug User Fee Act (PDUFA) date will be.
This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
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