Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity
Executive Summary
Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.
You may also be interested in...
Off-Label Opioid Promotion: US FDA ‘Does Not Object’ To Intranasal Deterrence Data, Egalet Says
In decision that reflects policy confluence of opioid abuse deterrence, off-label communications and marketing exclusivity, FDA will allow Egalet to distribute truthful, nonmisleading information about Arymo ER's intranasal abuse-deterrence data even though the long-acting opioid was blocked from receiving a labeling claim.
Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails
CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.
Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails
CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.