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

US FDA Puts Spotlight On Alkermes' Violative Vivitrol Ad

Executive Summary

The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.

You may also be interested in...



Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News

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

Comparative Claims: CFL Guidance Gives Opening; OPDP Research May Close It

US FDA’s 'consistent with labeling' guidance prompts more sponsors to consider comparative promotional claims, but any minimization of product safety issues still runs the risk of enforcement, legal experts say; Office of Prescription Drug Promotion’s research agenda on consumer understanding of Rx ad claims could result in an attempt to limit comparative claims.

US FDA Communications Post-Gottlieb: No Slow-Down In Statements, But Attribution Changes

Breakneck pace of press releases under former US FDA Commissioner Scott Gottlieb hasn’t abated in the early days of the Sharpless era – but the attribution has.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141349

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