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.