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.
Purdue pleads guilty to three felony charges over marketing of OxyContin under settlement that requires Purdue to be dissolved and transformed into an entity that provides addiction and overdose medicines. Twenty-five state AGs oppose creation of a PBC, arguing Purdue should be sold to another company.