www.fdanews.com/articles/187437-fda-approves-labeling-supplement-for-celebrex
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FDA Approves Labeling Supplement for Celebrex
July 2, 2018
The FDA approved a labeling supplement for Pfizer’s anti-inflammatory drug Celebrex (celecoxib).
The supplement will include results from a postmarketing study that found at its lowest dose the drug had a similar cardiovascular safety profile to naproxen and ibuprofen.
The study found that at 100 mg twice daily, the lowest approved dose for the drug, it is non-inferior to ibuprofen in the range of 600-800 mg three times daily or naproxen at 375-500 mg twice daily.