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FDA To Hold COX-2 Advisory Committee In Early 2005, Woodcock Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency will have to make a trade-off between getting products on the market and determining their cardiovascular safety profile. Merck believes placebo-controlled trials in osteoarthritis patients should not be longer than four months due to ethical concerns.

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Celebrex, Bextra Given Breathing Room In Latest FDA Advisory

Agency suggests any regulatory action on COX-2s or non-selective NSAIDs will wait until after a February advisory committee meeting. A public health advisory urges physicians to consider the “emerging” information on cardiovascular risk when prescribing COX-2s. FDA also orders a review of all prevention studies using Pfizer’s Celebrex and Bextra.

Celebrex, Bextra Given Breathing Room In Latest FDA Advisory

Agency suggests any regulatory action on COX-2s or non-selective NSAIDs will wait until after a February advisory committee meeting. A public health advisory urges physicians to consider the “emerging” information on cardiovascular risk when prescribing COX-2s. FDA also orders a review of all prevention studies using Pfizer’s Celebrex and Bextra.

COX-2 Advisory Committee Review Will Include New Celebrex Safety Data

Committee will also “explore ways of further evaluation” of the safety of Pfizer’s Bextra and COX-2s approved in Europe, such as Merck’s Arcoxia. FDA also expects discussion of broader NSAID category, at least for “context.”

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