Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Brand industry favors two- to three-year period for withdrawal or reformulation of products without abuse-deterrent features, while generic industry calls for expedited review pathway. Purdue and Zogenix agree to waive three-year market exclusivity for their respective hydrocodone products.

You may also be interested in...



Sharfstein On Zohydro: FDA Should Require Opioid Abuse Deterrent Standards

Former FDA Principal Deputy Commissioner Joshua Sharfstein suggests FDA create a pathway for development of new products for simultaneous treatment of chronic pain and opioid disorder.

Abuse Reduction Claim In Opioid Label Will Be Difficult To Attain

FDA draft guidance says there is no clear epidemiologic strategy for gathering the data to demonstrate that has reduced abuse; the agency outlines four possible kinds of abuse deterrence claims, three of which can be obtained through pre-market studies.

Second Judge Rejects Constitutional Challenges To Medicare Price Negotiation Program

Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS005602

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