Approval Might Be The Least Of Aralez's Challenges With Yosprala
If the aspirin/omeprazole finally gets approved on its third FDA review, Aralez then will face the challenge of positioning a prescription product against generic, over-the counter versions of both of its main components.
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The new company, to be formed through the merger of Pozen and Tribute, will develop a commercial organization to sell Yosprala and look to bring in new assets through licensing and M&A.
The company received a second “complete response” letter from FDA for Yosprala, its fixed-dose combination of aspirin and omeprazole, due to issues with the undisclosed third-party supplier.