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FDA extends review for Prevnar 13 for adults 50+

July 29, 2011 11:46 PM UTC

FDA extended the review period by three months for an sBLA from Pfizer Inc. (NYSE:PFE) for its Prevnar 13 pneumococcal vaccine to January 2012 from October. Pfizer is seeking accelerated approval to expand the label to include prevention of disease caused by 13 serotypes of Streptococcus pneumoniae in adults 50 years and over. Pfizer said it submitted additional data from two studies that were included in the sBLA, which the agency considered to be a major amendment. FDA's Vaccines and Related Biological Products Advisory Committee is slated to meet on Sept. 20 to discuss the application. ...