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

FDA Makes Broad Concessions In Settling Pacira Promotion Suit

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency will formally rescind Exparel warning letter and expand labeling to clarify that pain drug is not limited to any specific surgery.

You may also be interested in...



FDA’s Tactical Exparel Label May Suggest Broader Off-Label Strategy

Inclusion of failed studies in US label for Pacira’s Exparel label is unusual but appropriate given regulatory history with that application. Could FDA take that approach with other products to address unapproved uses in the context of uncertainty about prohibitions against 'off-label' promotion?

Pacira's Exparel Adds Nerve Block Indication For Shoulder Surgery In US

In unusual move, labeling lists data supporting use as nerve block as well as other trials that 'do not support' a broader nerve block indication beyond brachial plexus; labeling includes data on reduced opioid use but notes clinical benefit has not been established.

Pacira’s Long Day With Exparel

Many an unfortunate NDA sponsor has faced a long day when heading into US FDA advisory committee review. But Pacira faced a really long day for the review of a supplemental indication of Exparel. In fact, it was a day and a half. 

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS078085

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