Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

First Amendment Suit From Pacira Challenges FDA Labeling Interpretation

This article was originally published in The Pink Sheet Daily

Executive Summary

Speech about specific uses is within broad approved indication of post-surgical pain medication Exparel, Pacira argues.

You may also be interested in...



Pacira's Exparel: US FDA Panel Narrowly Rejects Nerve Block Claim

Inconsistent efficacy data and safety concerns about falls and systemic toxicity lead to advisory committee vote against a labeling expansion for the local anesthetic; Pacira's proposed revisions to the drug's existing infiltration claim also meet some resistance.

Pacira's Exparel Faces Efficacy Questions On Nerve Block Indication

US FDA advisory committee to weigh whether efficacy data support an expanded label for the local anesthetic; despite Pacira's completion of two new studies following a complete response letter, FDA continues to harbor concerns about adequacy of the data to support a broad nerve block claim.

Pacira's Exparel For Nerve Block Use Gets Day-Plus US FDA Panel Review

Pacira believes new clinical trial of post-surgical pain medication will satisfy FDA concerns raised in complete response letter for its supplemental NDA.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS078993

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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