Aralez Announces FDA Acceptance of New Drug Application for YOSPRALA™

MILTON, Ontario, Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has acknowledged acceptance of the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016.

"The acceptance of our NDA for YOSPRALA marks an important and exciting step toward approval of this product," said Adrian Adams, Chief Executive Officer of Aralez. "We look forward to working with the FDA during the review process in order to bring YOSPRALA to market as quickly as possible."

Source: Aralez Pharmaceuticals Inc.