FDA Panel Recommends Against U.S. Approval for Merck's Arcoxia
April 13, 2007
GAITHERSBURG, Md. - An advisory panel to the FDA, in a nearly unanimous vote, has recommended against approving Merck & Co. Inc.'s selective Cox-2 inhibitor Arcoxia (etoricoxib) for sale in the United States for the treatment of osteoarthritis.
The 20-1 vote on April 12 by the FDA's Arthritis Advisory Committee, made up of outside medical experts, is nonbinding upon the FDA's ultimate decision regarding Merck's potential successor arthritis drug to the company's withdrawn Vioxx. However, the recommendation is expected to carry weight with FDA officials, whose formal decision is expected by April 27.
If approved, Arcoxia would be the first …
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