FDA Has One Month To Mull Approval Of Merck's Arcoxia Following Vioxx Withdrawal
This article was originally published in The Pink Sheet Daily
Executive Summary
Arcoxia's user fee date is Oct. 30, but FDA could decide to wait for 18-month cardiovascular safety data from a 20,000-patient trial comparing etoricoxib with diclofenac. Merck says it will work with regulatory authorities in 47 countries where Arcoxia is marketed to discuss potential labeling changes resulting from the Vioxx study data.
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