4.28.2007

FDA rejects Merck's Vioxx successor


TRENTON, N.J. - The Food and Drug Administration rejected Merck & Co.'s request to market a successor to its withdrawn arthritis drug Vioxx in the United States, the drugmaker said Friday.

The move was widely expected, after a panel of FDA advisers two weeks ago voted 20-1 against approving the drug, Arcoxia.

Arcoxia is in the same class of drugs as Vioxx, which has become a poster child for drug safety problems.

Merck pulled Vioxx from the market in September 2004 after research showed it doubles risk of heart attacks and strokes. That triggered an avalanche of lawsuits — more than 27,000 so far — and a nosedive for Merck's stock price, which has since bounced back.

Despite the safety concerns in the United States, Arcoxia is on sale in 63 other countries, and Merck officials said as recently as Tuesday that they intend to keep working to get it on the U.S. market.

Merck shares sank 55 cents, or 1 percent, to $51.88 in morning trading on the New York Stock Exchange. They are still trading near their 52-week high of $52.63. Their low over the past year was $32.75.

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