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

UsernamePublicRestriction
UsernamePublicRestriction

Can FDA Finally Put Its Zohydro Problem Behind It?

Executive Summary

FDA sees progress on the opioid front with Zogenix and Teva the latest to seek abuse-deterrence claims, but is the existing science able to adequately fight abuse?

You may also be interested in...



Opioid Market Snapshot: No Pain, No Gain For Abuse-Deterrence Claims

Abuse-deterrent opioids address a serious unmet need and help differentiate brands from the field of generics, but so far Purdue’s OxyContin remains the only opioid on the market with abuse-deterrent claims, even though FDA recently approved two new opioid analgesics.

FDA’s Opioid Guidance: Industry Celebrates Multi-Tiered Labeling Cake

Endo says label differentiation in the guidance is a positive step; Commissioner Hamburg tells Congress that if new opioid formulations “significantly” deter abuse, generic versions will have to as well.

The Evolution Of US FDA Advisory Committee Votes On COVID-19 Vaccines

From surprisingly contentious to surprisingly unanimous, VRBPAC's favorable votes have grown from 17 to 21 over the course of three meetings on coronavirus vaccines.

Topics

Related Companies

UsernamePublicRestriction

Register

OM004078

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

Cancel