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

Opioid Sponsors Enter 2019 At A Crossroads

Executive Summary

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the analgesics to market. 
Advertisement

Related Content

Keeping Track: FDA Clears Motegrity And Second Herceptin Biosimilar, But Rebuffs SpecGx's Oxycodone
Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing
Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control
Dsuvia Approval May Be Followed By New Opioid Review Paradigm At FDA
Opioid Policy At US FDA: Over-Promising Or Overreacting?
Opioid Blister-Pack Mandate Tops Gottlieb's Agenda With New Authority
Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory
Patient Testimony Highlights Difficulties Of Pain Drug Development, US FDA Regulation Of Opioids
New Opioids: FDA Should Ditch 'Product-Specific Approach,' Science Report Says
Abuse-Deterrent Opioids: Postmarketing Data Eyed As Development ‘Anchor’

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS124466

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