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

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

Executive Summary

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.

You may also be interested in...



Complete Response Letters See Uptick With US FDA's Thumbs Down For Waylivra

In first half of 2018, CRLs were rarely issued for CDER-regulated novel agents, but FDA's rejection of Waylivra marks second in two weeks.

Keeping Track: Thumbs Up For Doptelet And Palynziq, Thumbs Down For Methylene Blue MMX And Meloxicam

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

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?

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM007466

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