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FDA Rejects Merck's Latest COX-2 Drug

Law360 (April 30, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration has rejected Merck & Co.’s bid for approval of its painkiller and osteoarthritis treatment Arcoxia, a drug that is in the same class as Vioxx, over which the company faces a slew of lawsuits.

Merck received a “non-approvable letter” from the FDA on Friday in response to its New Drug Application for Arcoxia. The FDA said Merck would have to provide additional data on Arcoxia to garner regulatory approval.

“We’re evaluating the letter,” said Merck spokesman Ron Rogers on Monday....
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