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FDA Sets High Bar For Approval Of Merck’s COX-2 Arcoxia

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Arthritis Drugs Advisory Committee will review Merck’s Vioxx follow-on etoricoxib during an April 12 meeting.

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Arcoxia Advisory Committee Will Be Missing Key Participants From 2005 COX-2 Meeting

Many of the key panelists during the 2005 advisory committee review of COX-2 inhibitor cardiovascular safety will not be participating in the Arthritis Advisory Committee's April 12 review of Merck's Vioxx follow-on Arcoxia

Merck Seeks Narrowed Arcoxia Indication In Response To “Approvable” Letter

Company expects to hear from FDA in April on 30 mg and 60 mg once-daily doses of the Vioxx follow-on drug.

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