FDA Latest Opioid Dilemma: Can Apadaz Stop Snorting Abuse – And Does That Even Matter?
This article was originally published in The Pink Sheet Daily
KemPharm's immediate-release hydrocodone combination product has limited data about a route of abuse that FDA believes is a relatively small aspect of the epidemic.
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Keeping Track: Apadaz Approved Without Abuse-Deterrent Label, FDA Denies Translarna Appeal, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
Sponsor hopes to demonstrate that FDA's process for reviewing extended-release abuse-deterrent opioids may not be appropriate for an immediate-release product. Apadaz would be the first immediate-release opioid with an abuse-deterrent claim if approved.
Patent office requests comments on its proposed initiatives, with continuation patents appearing a particular target. PTO asks if filing a terminal disclaimer for patents that are a variation of each other should be an admission they are obvious.