Keeping Track: A Lilly Breast Cancer Approval, A Couple Of CRLs, And A Plethora Of Priority Reviews
The latest drug development news and highlights from our Performance Tracker.
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With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.
The latest drug development news and highlights from our US FDA Performance Tracker.