Pink Sheet is part 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


Opioid Indication Change Could Draw Legal Challenge From Physicians Group Seeking More Restrictions

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA tells sponsors to revise the indication for the ER/LA analgesics to highlight appropriate patient selection rather than severity of pain and orders post-marketing studies to identify a dose and duration-of-treatment associated with higher rates of abuse, misuse, addiction, overdose and death.

You may also be interested in...

Purdue Puts Forth FDA Decisions As Defense To Massachusetts Opioid Suit

Purdue says Commonwealth is trying to hold it liable for conduct FDA has authorized; citing agency's approval of long-term use of OxyContin for chronic pain, company asks court to dismiss complaint.

Opioids And The Limits Of FDA Power

FDA adds a MedGuide for immediate-release opioids and shrinks their indication; the products seemed destined for an educational REMS, but is there even more the agency could do?

Opioid Use For Chronic Pain Would Be Restricted Under CDC Guideline

Draft guideline recommends limiting dosing to equivalent of 90 mg of morphine per day and limiting use to three days after acute injury.

Related Content





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