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Cardiovascular Warning Boosts Profile For OTC NSAID Label Changes

This article was originally published in The Tan Sheet

Executive Summary

FDA more commonly requires similar changes for prescription drug labels based on emerging science on potential risks, but for non-aspirin NSAID label changes CDER also will contact OTC firms and advise them of changes needed to cardiovascular risk warnings on their product labels. “It doesn’t happen on quite the scale that we’re dealing with here and with the nature of these products,” says attorney Frederick Stearns.


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