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

Purdue Petition Seeks FDA Commitment To “Adapted” Studies For OxyContin Generics

This article was originally published in The Pink Sheet Daily

Executive Summary

Company says a generic should be equivalent or better than reformulated OxyContin on all the tests to ensure it has equivalent abuse-deterrent capabilities.

You may also be interested in...



FDA’s Opioid To-Do List Could Redefine Pain Market For Brands, Generics

Supporters of narrowing opioid drugs’ non-cancer pain indication tell FDA that pain patients often suffer the consequences of addiction and misuse.

FDA Opioid Guidance Is Silent On Generics, Cautions That Addicts Can Erase Labeling

Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of generic-related citizen petitions continues.

Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS075209

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