FDA Approves Labeling Supplement for Celebrex

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.