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FDA delays Prevnar 13 action to year end

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA moves the user fee action date for Wyeth's pneumococcal vaccine Prevnar 13 from Sept. 30 to Dec. 30 so it can consider additional information submitted at the agency's behest in July, the drug maker announces Aug. 11. The data constitute a major amendment to the BLA submitted in March (1"The Pink Sheet" DAILY, April 1, 2009). The amendment contains additional analytical method validation and specification information related to physical/chemical properties of the vaccine. The conjugate vaccine is under review for active immunization of infants and young children for prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae serotypes, six more than the currently approved Prevnar, which has been available in the U.S. for over nine years

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