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FDA releases Pfizer after SINCERE patient recruitment challenges

This article was originally published in Scrip

Executive Summary

Pfizer has called an end to its SINCERE study designed to collect long-term safety data for Celebrex (celecoxib) in paediatric patients with juvenile idiopathic arthritis (JIA), despite the fact that Celebrex was only granted US FDA approval on the condition that the post-marketing study was conducted.

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