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


Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.

You may also be interested in...

Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing

All metrics for assessing the effectiveness of the Risk Evaluation and Mitigation Strategy for long-acting/extended release opioids may not be in place when FDA approves REMS for individual products.

Cephalon’s Fentanyl Drugs Join Class-Wide REMS; Shared System Still To Come

Cephalon’s Actiq and Fentora will undergo increased distribution restrictions after joining FDA’s class-wide REMS for transmucosal fentanyl drugs, but a shared system, one of the main tenets of the risk management plan, is still under development.

Can New Pain Drugs Break Through To A Growing Cancer Market and Beyond?

Two new drug approvals represent the latest innovations in the emerging area of breakthrough cancer pain, designed to ease intense, short-term waves of heightened suffering in patients who are already taking opioids for persistent background pain.

Related Content


Related Companies

Latest Headlines
See All



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