Issued: Friday 15 April 2011, Philadelphia, PA

GlaxoSmithKline [NYSE:GSK] today submitted additional information to the U.S. 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 June 11, 2010 Complete Response letter received from the FDA.

The proposed indication for this combination vaccine is immunization of infants and toddlers against meningococcal serogroups C & Y, and Haemophilus influenzae type b (Hib) diseases at two, four, six and 12-15 months of age.  

GSK will continue to work closely with FDA as the Agency continues its review. 

GlaxoSmithKline Biologicals – GlaxoSmithKline Biologicals (GSK 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. For further information please visit www.gsk.com .

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com .
 

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