FDA Delays Decision on Wyeth Drug
The Food and Drug Administration has delayed by three months a decision on kidney cancer drug Torisel from Wyeth(WYE Quote).
The company announced Friday that the FDA wanted an extra three months to review additional data that it has requested from Wyeth on the drug. The original FDA action date was April 5. (U.S. stock markets were closed Friday in observance of Good Friday.)
"We are encouraged by the review process so far, and, with the submission of these analyses, we remain optimistic about the prospects for strengthening the product labeling for launch in the third quarter of 2007," said Robert Ruffolo, Jr., a senior vice president, in prepared comments Friday. ...
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