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Wyeth Provides Regulatory Update on Prevnar 13* in the United States
Date:8/11/2009

COLLEGEVILLE, Pa., Aug. 11 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced it received notice that the action date for the U.S. Food and Drug Administration's (FDA) review of the Biologics License Application (BLA) for Prevnar 13(TM), (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) has been extended 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. FDA considered this to be a major amendment and, as a result, they have elected to extend the review cycle for Prevnar 13 by 90 days. Prevnar 13 is under review for active immunization of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.

"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," says Emilio Emini, Ph.D., executive vice president, Vaccine Research and Development, Wyeth Pharmaceuticals. "Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance. We continue to believe that our application supports the approval of Prevnar 13."

Prevnar 13(TM) is based on the scientific foundation of Prevnar(R) (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the standard in pneumococcal disease prevention for infants and young children. It contains the seven serotypes in Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional serotypes (1, 3, 5, 6A, 7F and 19A) respon
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