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

Prexige 2007 Filing Target Assumes FDA Will Request Additional CV Data

This article was originally published in The Pink Sheet Daily

Executive Summary

Novartis assumes FDA will require two-year cardiovascular data for COX-2s following the withdrawal of Merck's Vioxx. Company expects to have "more detailed discussions" with the agency in early 2005 after FDA reviews 12-month data from the Prestige TARGET study.

You may also be interested in...



Novartis Will Resubmit COX-2 Inhibitor In The U.S. In 2007

Prexige is approved in EU and Canada for osteoarthritis symptoms, company announces.

Novartis Will Resubmit COX-2 Inhibitor In The U.S. In 2007

Prexige is approved in EU and Canada for osteoarthritis symptoms, company announces.

COX-2 Pipeline Drugs Will Need Additional Cardiovascular Data, FDA Says

COX-2 inhibitors in the R&D pipeline will need additional cardiovascular safety data prior to approval under FDA's risk management program for the drug class

Related Content

Topics

UsernamePublicRestriction

Register

ID1132956

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