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

 
• By Joseph Haas

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.

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...

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