- The FDA accepts Pozen's (NASDAQ:POZN) resubmission of its NDA for PA8140/PA32540 and sets a PDUFA date of December 20, 2014. The agency sent the company a CRL on April 25, 2014 citing deficiencies in the manufacturing facility of an ingredient maker.
- The company has agreed substantively to the FDA's most recent product labeling draft.
- PA8140/PA32540 contains 325 mg delayed release aspirin and 40 mg immediate-release omeprazole for patients who require aspirin therapy. The combination decreases the risk of developing aspirin-associated gastric ulcers.
- POZN shares are down 6% premarket on modest volume.