Pfizer's Parecoxib Ad Cited By U.K. For Using Out-Of-Date Labeling
This article was originally published in The Pink Sheet Daily
Executive Summary
A journal ad for parecoxib, marketed as Dynastat in the U.K., did not mention two warnings recently added to the COX-2 inhibitor for use in congestive heart failure and coronary artery bypass graft patients. The Medicines & Healthcare Products Regulatory Agency is requesting a corrective statement. The parecoxib NDA is pending at FDA.