Opioids: Intellipharmaceutics' Pursuit Of IV-Only Deterrence Claim May Backfire
US FDA advisory committee may not be comfortable with intravenous abuse-deterrence labeling for Rexista (oxycodone extended-release) when the sponsor has not assessed the impact on other routes of abuse purportedly targeted by the formulation.
You may also be interested in...
The latest drug development news and highlights from our US FDA Performance Tracker.
The latest drug development news and highlights from our Performance Tracker.
FDA-commissioned study recommends agency consider things like off-label use and risks of transition to illicit drugs in opioid approval decisions; opposes restricting market to abuse deterrent formulations.