Celebrex, NSAID Labeling Must Be Updated Within Three Months, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's labeling template calls for Pfizer's Celebrex and other prescription NSAIDs to add "black box" warnings on cardiovascular and gastrointestinal risks. FDA is also requiring a warning on skin reactions. The agency issues a medication guide for all NSAIDs.