Supplemental NDA submitted for Prevnar 13 in older adults
Pfizer announced that it has submitted a supplemental NDA (sNDA) to the FDA to expand the use of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to adults ≥50 years of age for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine. More specifically, Pfizer is seeking approval to market Prevnar 13 for the active immunization of older adults for the prevention of pneumococcal disease (including pneumonia and invasive disease) caused by the Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine. The FDA is targeting a review cycle of 10 months from the application's submission date, resulting in an expected action date in October 2011, subject to the FDA's acceptance of the application.
Prevnar 13 was approved earlier in 2010 for the prevention of invasive pneumococcal disease and otitis media in children 6 weeks through 5 years of age.
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