The US FDA is likely to okay a labeling revision for Pfizer Inc.'s Celebrex (celecoxib) to include data from its PRECISION trial now that an advisory panel has voted 15 to 5 (with one abstention) that the study showed the drug's cardiovascular safety is comparable to naproxen and ibuprofen.
The agency's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held a joint meeting April 24-25 to...