GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies, announced that the company has submitted additional information to the US Food and Drug Administration (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 Agency continues its review.

GlaxoSmithKline Biologicals, GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development.