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

Pacira's Exparel Faces Efficacy Questions On Nerve Block Indication

Executive Summary

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.

Advertisement

Related Content

Opioid-Sparing Claims Should Meet High Bar, US FDA Panel Says
Pacira's Exparel: US FDA Panel Narrowly Rejects Nerve Block Claim
Pacira's Exparel For Nerve Block Use Gets Day-Plus US FDA Panel Review
FDA Makes Broad Concessions In Settling Pacira Promotion Suit
First Amendment Suit From Pacira Challenges FDA Labeling Interpretation

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS122503

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