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OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

Safety study of celecoxib vs. ibuprofen and naproxen spurs advisory committees to recommend adding aspirin-interaction warning on OTC naproxen labels, but many panelist made clear that PRECISION results had not swayed their thinking on celecoxib CV safety or on the OTC ingredients' interaction with aspirin.

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