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

US FDA Proactively Exploring Hydexor Abuse Potential Ahead Of Ad Comm For Anti-Emetic/Opioid Combo

Executive Summary

Charleston Labs is not seeking abuse-deterrent labeling for Hydexor, but FDA has been monitoring online web forums to spot patterns of abuse of the active ingredients to determine if inclusion of promethazine translates to greater risk of abuse than for other hydrocodone products.

Advertisement

Related Content

Opioids: US Senate Committee Chairman's Discussion Drafts Broadly Reflect FDA Priorities
US FDA Advisory Cmte. Review Of Charleston's Hydexor Exposes Flaws In Commercial Strategy
Charleston's Anti-Emetic/Opioid Combo Flops At US FDA Panel Over Postmarketing, Dosage Concerns
US FDA Monitoring Online Forums For Research Into Opioid Misuse And Abuse
Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns
KemPharm's Opioid Apadaz Will Likely Miss Out On Abuse Deterrence Claim

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS122508

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