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

Executive Summary

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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Aralez Pharma, Anchored In Cardiovascular, Will Be Prowling For Assets

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.

More Bad News For Pozen: Another Delay To Market For Yosprala

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.

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