Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine
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 September 2011 Complete Response letter received from the FDA.
- (1888PressRelease) December 05, 2011 - 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 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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