Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep.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CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep.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.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS120117

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel