FDA approved adding the results of the PRECISION cardiovascular outcomes trial to Pfizer Inc.'s Celebrex (celecoxib) label, while emphasizing that it is the lowest approved dose of Celebrex that was shown to have comparable CV risk to moderate doses of naproxen and ibuprofen.
Addition Of Celebrex PRECISION Cardiovascular Trial to Label Emphasizes Use Of Lowest Dose
Heeding concerns of an advisory panel, US agency underscores that it is the lowest approved dose of the COX-2 inhibitor that has comparable CV risk to moderate doses of ibuprofen and naproxen.
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