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Wyeth Provides Regulatory Update on Prevnar 13 in the United States
Wyeth, 08/12/09

Wyeth Pharmaceuticals, a division of Wyeth, announced it received notice that the action date for the U.S. Food and Drug Administration's review of the Biologics License Application for Prevnar 13, has been extended from September 30, 2009, to December 2009. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July.

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