Yosprala 325/40 regulatory update

FDA issued a second complete response letter for a combined NDA from Pozen for its aspirin/omeprazole products, Yosprala 81/40 ( PA8140) and Yosprala 325/40 (PA32540), 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 compete response letter issued in April, citing “inspection deficiencies” at the facility of a foreign third-party manufacturer of an active ingredient (see BioCentury, May 5).

Pozen said the agency has not conducted a new inspection of the facility since April and noted that the supplier provided the FDA with a plan to address the deficiencies in May. It declined to disclose the manufacturer or its location. The company said it will request a meeting with FDA to discuss a path forward. ...