ARTICLE | Company News

Pozen falls on second complete response

December 18, 2014 2:27 AM UTC

Pozen Inc. (NASDAQ:POZN) lost $0.93 (10%) to $8.10 after FDA issued a second complete response letter for the company's Yosprala combinations of aspirin and omeprazole for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

The company said FDA used the same language from its first CRL in April, citing "inspection deficiencies" at the facility of a foreign third-party manufacturer of an active ingredient (see BioCentury Extra, April 28). ...