BioCentury
ARTICLE | Company News

Complete response for Pozen products

April 29, 2014 12:30 AM UTC

Pozen Inc. (NASDAQ:POZN) said FDA issued a complete response letter for a combined NDA for PA32540 and PA8140 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. According to the company, FDA cited "inspection deficiencies" at the manufacturing facility of a third-party supplier of an active ingredient. Pozen said it plans to submit a response "as soon as possible" and that no clinical or safety deficiencies were noted. The company said an agreement with FDA on the labeling is pending.

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, and PA8140 comprises 81 mg aspirin. ...