Celebrex gets closer to revised label in USA

Like their rival Merck & Co, Pharmacia and Pfizer have been sent anapprovable letter from the US Food and Drug Administration for revised labeling for their COX-2 inhibitor Celebrex (celecoxib). Merck received a similar letter for its competing drug Vioxx (rofecoxib) earlier this month (Marketletter April 16).

A statement issued by Pharmacia and Pfizer noted that the approvable letter was for a revision to the labeling to include the results of the Celecox Long-term Arthritis Safety Study (CLASS). In February, an FDA advisory panel declined to give its backing to an application by Pharmacia seeking the removal of a warning, which appears on all NSAIDs, that their use may be associated with GI ulcers and bleeding (Marketletter February 19), but it now seems likely that Celebrex' label will make reference to the fact that it has been found to have fewer GI side effects than ibuprofen, the comparator drug in the CLASS study.