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

COX-2 Class Labeling From Vioxx/Celebrex Data Proposed By FDA Consultant

Executive Summary

Class labeling for COX-2 inhibitors incorporating data from Pharmacia's Celebrex and Merck's Vioxx large-scale safety studies may be useful in explaining differential safety results in gastrointestinal and cardiovascular adverse events, a consultant to FDA's Arthritis Advisory Committee suggested Feb. 8.

You may also be interested in...



Vioxx Label Balances CV Risk With GI Safety: Can Merck Reverse Damage?

The Vioxx labeling change will allow Merck to discuss the COX-2 inhibitor's cardiovascular safety profile in the context of a rheumatoid arthritis indication and a gastrointestinal safety benefit

Vioxx Label Balances CV Risk With GI Safety: Can Merck Reverse Damage?

The Vioxx labeling change will allow Merck to discuss the COX-2 inhibitor's cardiovascular safety profile in the context of a rheumatoid arthritis indication and a gastrointestinal safety benefit

Pharmacia To Publish Full 12-Month Data From CLASS Study Of Celebrex

Pharmacia is preparing to publish the full 12-month data from the Celebrex CLASS GI outcomes study.

Related Content

UsernamePublicRestriction

Register

PS037350

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