The FDA has extended the action date for its review of Prevnar 13’s BLA from September 30, 2009, to December 30, 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. According to Wyeth, the FDA considered this to be a major amendment and, as a result, has elected to extend the review cycle for the vaccine by 90 days. Prevnar 13 is under review for acti...