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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."
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