Wyeth Pharmaceuticals, a division of Wyeth , today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes (1, 3, 5, 6A, 7F and 19A) in addition to the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVNAR(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
The details can be read here.
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