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

Pfizer Will Study Oxecta Abuse/Misuse Potential Post-Market

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA okays the opioid, which contains abuse-resistant components, with labeling about a study that found the drug less likeable than immediate-release oxycodone.

You may also be interested in...



Keeping Track: Cardio, Antibiotic Approvals Put FDA Over Last Year's Novel Drug Count

The latest drug development news and US FDA highlights from our Performance Tracker.

When Is An Abuse-Deterrent Claim FDA Approved?

Agency says it is seeing confusion in the marketplace when it comes to distinguishing between agency-approved labeling claims and advertising about products that are intended to be abuse deterrent.

Purdue NDA For Oxycodone/Naloxone Combo Tests New FDA Policy

The sponsor believes its data package could support a labeling claim that the drug “is expected to result in a meaningful reduction in abuse”; the agency’s review could indicate the strength of data needed to support such a claim.

Related Content

Topics

UsernamePublicRestriction

Register

PS072393

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