Safety Studies Should Be Required To Retain Celebrex, Bextra Approval – Researcher
This article was originally published in The Pink Sheet Daily
Executive Summary
Revised approval standards for COX-2 inhibitors still in development should be extended to marketed drugs "as a condition of their retention of approval," Penn researcher FitzGerald tells FDA advisory committee. FitzGerald says Vioxx safety signal is a class effect, calls Pfizer's argument that it is restricted to rofecoxib an "off-target fantasy."