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

Opioid Abuse Deterrence: Purdue Expects Quick Results On OxyContin, But Cmte. Wonders About Duration Of Effect

This article was originally published in The Pink Sheet Daily

Executive Summary

The surveillance system for tracking adverse events associated with the reformulated drug continues to evolve, the firm tells an FDA advisory panel.

You may also be interested in...



No Abuse-Resistance Claim For Endo’s Opana ER Reformulation

Endo’s Opana ER reformulation, which uses proprietary technology to deter crushing, receives approval but no labeling language on crush-resistance or abuse deterrence, according to FDA. The company says a U.S. patent to be issued Dec. 13 will protect the new formulation until November 2023.

Abuse-Resistant Opioids: How Much Deterrence Is Enough For A Labeling Claim?

FDA advisory committee will consider post-market study plans for King's Embeda and Purdue's reformulated OxyContin.

Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind

Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071340

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