Approval Might Be The Least Of Aralez's Challenges With Yosprala

Canadian specialty firm Aralez Pharmaceuticals Inc. is confident that its heart attack and stroke-prevention combination product Yosprala will gain FDA approval on a third review, but that will only be the beginning of the company's challenge as it attempts to position the controlled-release formulation of aspirin and omeprazole against generic and over-the-counter products.

Yosprala combines aspirin with the proton pump inhibitor omeprazole (AstraZeneca PLC's Prilosec and generics) to improve tolerability. Aralez's predecessor Pozen Inc. received two FDA complete response letters due to inspection deficiencies at a supplier: it brought in a new supplier for the aspirin component of the combination product and re-filed its NDA, which has an action date of Sept. 14