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ARTICLE | Clinical News

FDA approves CV label update for Pfizer's Celebrex

June 29, 2018 6:23 PM UTC

FDA approved a label supplement for Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) to include data from a postmarketing cardiovascular outcomes trial showing that the lowest approved dose of Celebrex had similar CV safety to that of moderate doses of naproxen and ibuprofen.

In April, FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that the Phase IV CV outcomes PRECISION trial showed that Celebrex had comparable CV safety to non-selective NSAIDS naproxen and ibuprofen on a composite CV endpoint comprising CV death, non-fatal myocardial infarction (MI), and non-fatal stroke (see "FDA Panel Affirms Safety of Pfizer's Celebrex")...

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