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news.The US Food and Drug Administration (FDA) has acknowledged acceptance of the New Drug Application (NDA) for Aralez Pharmaceuticals' investigational candidate, YOSPRALA (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
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The FDA Prescription Drug User Fee Act ("PDUFA") goal date for a decision is September 14, 2016.
Aralez CEO Adrian Adams said: "The acceptance of our NDA for YOSPRALA marks an important and exciting step toward approval of this product.
"We look forward to working with the FDA during the review process in order to bring YOSPRALA to market as quickly as possible."
About YOSPRALA
The company has developed an investigational aspirin therapy, known as YOSPRALA 81/40, containing 81 mg of aspirin, and YOSPRALA 325/40, containing 325 mg of aspirin.
Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.
This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.