Effexor-Pro - FDA decision Delayed

Posted by ttee on August 30, 2006, at 8:57:38

FDA Decision on Wyeth Drug Delayed
Tuesday August 29, 5:30 pm ET
Wyeth's Depression Drug Application Is Extended 3 Months by the FDA, to Jan. 22
MADISON, N.J. (AP) -- Drug developer Wyeth said Tuesday the Food and Drug Administration delayed a decision on the approval of an extended release version of its depression treatment.
The company had resubmitted data on the drug, desvenlafaxine succinate extended release, on July 31. That was during the last three months of the FDA's approval process. The FDA has the option to extend its typical 10-month review if the developer submits new information or amendments.
Wyeth said the deadline extension is not likely to affect its plans to launch the drug next year. The agency is now expected to make a decision by Jan. 22.
Shares of Wyeth rose 40 cents to close at $48.70 on the New York Stock Exchange.

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Effexor-Pro - FDA decision Delayed ttee 8/30/06

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