More Bad News For Pozen: Another Delay To Market For Yosprala
This article was originally published in The Pink Sheet Daily
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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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.