FDA accepts NDA for Aralez's Yosprala

Aralez Pharmaceuticals Inc. (NASDAQ:ARLZ; TSX:ARZ) said FDA accepted an NDA for Yosprala 325/40 ( PA32540) and Yosprala 81/40 ( PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The application's PDUFA date is Sept. 14.

FDA has rejected two prior applications for the Yosprala combination. In both complete response letters, the agency citied "inspection deficiencies" at the facility of a foreign third-party manufacturer (see BioCentury Extra, Dec. 17, 2014). ...