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

Teva's Vantrela Gets FDA Panel Nod For Three Abuse-Deterrent Claims

This article was originally published in The Pink Sheet Daily

Executive Summary

Hydrocodone extended-release product is an incremental improvement in deterring oral, intranasal and intravenous abuse, committee says.

You may also be interested in...



Abuse-Deterrent Opioids Effectiveness, Value To Get ICER Review

Pending arrival of several new products prompts evaluation of class, ICER CSO Dan Ollendorf explains; availability of both abuse-deterrent and non-abuse-deterrent drugs among challenging issues.

Opioid Approval Standards Not Up For Debate, FDA Tells Advisory Cmte.

As Egalet's Arymo ER heads to panel, agency tries to head off discussion about whether it should be approving new opioid products and whether longer clinical efficacy trials should be demanded.

Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL

In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS079586

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