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Pharmacia/Pfizer Celebrex

Executive Summary

sNDA submitted June 13 for inclusion of 13-month ulcer incidence study data in labeling. The study, comparing 400 mg celecoxib twice daily to traditional NSAIDs, found no significant difference between the therapies for the primary endpoint of serious complications. However, a significant difference was seen in the combined rate for serious complications and symptomatic ulcers (1"The Pink Sheet" April 24, p. 11)

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