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 posed a broad question to members of the Arthritis Advisory...
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