Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Endo Sees Regulatory Setting For Opana ER As "A Moving Target"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The “complete response” letter for the crush-resistant formulation of Endo Pharmaceuticals’ chronic pain drug Opana ER (oxymorphone) is not surprising, given that FDA has yet to settle on a risk management approach for extended-release opioids.
Advertisement

Related Content

FDA Standardizes REMS Documents For Certain Fentanyl Products
The REMS Filibuster: FDA Wants Ability To End Post-Approval Talks, Make Final Decision
Endo To Gain Full Control Over Leading Growth Product In Penwest Purchase
Endo To Gain Full Control Over Leading Growth Product In Penwest Purchase
FDA Opioid REMS Proposal Leaves Advisory Panel Wanting More - i.e. Mandatory Training
REMS For Individual Opioids Show FDA Flexibility, Keep Class Options Open

Topics

Advertisement
UsernamePublicRestriction

Register

PS004643

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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