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)
You may also be interested in...
Searle To Discuss Adding Celebrex 13-Month Safety Data To Label With FDA
Searle plans to approach FDA with data from a 13-month trial comparing the ulcer incidence for Celebrex to other nonsteroidal anti-inflammatory drugs, seeking a label change for the COX-2 inhibitor.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials