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.
You may also be interested in...
Keeping Track: Opdivo Dosing Simplified; Yosprala, Cuvitru Approved; Telotristat Review Lengthened
The latest drug development news and highlights from our FDA Performance Tracker.
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.