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.

Drugs and pills in the shape of a human heart.

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.

The agency followed the advice of an advisory panel, which spent two days reviewing data from the 10-year study. FDA...

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