GSK Submits Additional Information for Combination Vaccine
GlaxoSmithKline has submitted additional information to the FDA in support of the Biologics License Application for its candidate meningococcal and Hib combination vaccine.
UK healthcare company GlaxoSmithKline has submitted additional information to the U.S. FDA in support of the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine MenHibrix? (Hib-MenCY-TT).
This information was submitted in response to the September 2011 Complete Response letter received from the FDA.
The proposed indication for this combination vaccine is active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib).
GSK will continue to work closely with FDA as the Agen
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