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

Opioid Abuse-Deterrent Labeling Claim Decision By FDA Could Come Soon

Executive Summary

Purdue epidemiological studies indicate reformulation of OxyContin had a positive effect on abuse and misuse of the drug, but the company says continued monitoring is needed to assess whether the positive trend continues.

Advertisement

Related Content

Opioid Compounding Restrictions Could Create New Headaches For FDA
Pfizer’s Embeda Joins Abuse-Deterrent Club, But FDA Wants Assurances
FDA Crushes Endo’s Hopes, Allows Original Opana Generics To Remain On Market
OxyContin’s Abuse-Deterrent Claims Strong, But Stronger Claims Possible
OxyContin Revised Labeling Expects Less Abuse Via Injection, Snorting
FDA’s Opioid To-Do List Could Redefine Pain Market For Brands, Generics
Citizen Petition Seeks Limited Opioid Drug Indication To Curb Overuse And Abuse
No Abuse-Resistance Claim For Endo’s Opana ER Reformulation
Pfizer Will Study Oxecta Abuse/Misuse Potential Post-Market
Tamper-Resistance Could Allow New Opioid Formulations To Differentiate Themselves

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS055260

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