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

Esteve’s Tramadol/Celecoxib: US FDA Cites No Major Concerns, But Also No Advantages

Executive Summary

Agency’s briefing document for 15 January review of the fixed-dose product combining an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.

You may also be interested in...



US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

One Loss, One Tie: US FDA Panels Prove Difficult For Opioid Sponsors Intellipharmaceutics, Esteve

Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.

Durect's Posimir: NDA Resubmission Raises Similar Safety Issues

How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141480

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