Pink Sheet is part of the Informa 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

Neuromed's Extended Release Hydromorphone Gets Committee Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Exalgo will be another test of FDA's willingness to approve opioids in the absence of a class-wide REMS.
Advertisement

Related Content

Onsolis' REMS Is Not Template For Long-Acting Opiates - FDA
Deals Of The Week: J&J/TB Alliance, Watson/Arrow, GSK/Dr. Reddy's...
Opioids Pending At FDA Held Up By Anti-Abuse Claims, Not REMS Planning
REMS For Opioids Still Has A Long Road Ahead; Advisory Committee Is Likely
Opioid Class REMS: FDA Wants Prescriber/Pharmacist Certification
Opioid Class REMS: FDA Wants Prescriber/Pharmacist Certification

Topics

Advertisement
UsernamePublicRestriction

Register

PS069821

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