Regulatory Update: GlaxoSmithKline Receives Complete Response Letter from FDA for candidate meningococcal and Hib combination vaccine
PHILADELPHIA, Sept. 23, 2011--GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix® (Hib-MenCY-TT). 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).
This is the second response letter GSK has received for Hib-MenCY-TT. A Complete Response letter is issued by the FDA when the review of a file is completed and questions remain to be answered prior to approval. GSK will work to respond to the questions posed by the FDA.
The company remains committed to making this vaccine available in the United States.
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 visitwww.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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GlaxoSmithKline cautionary statement regarding forward-looking
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2010.
Posted: September 2011