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MenHibrix

Treatment for Haemophilus influenzae Prophylaxis, Meningococcal Meningitis Prophylaxis

Update: MenHibrix Now FDA Approved - June 14, 2012

Regulatory Update: Glaxosmithkline Submits Additional Information for Candidate Meningococcal and Hib Combination Vaccine

Philadelphia, Pa., Dec. 1, 2011 -GlaxoSmithKline 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.

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

GlaxoSmithKline Enquiries:

UK Media enquiries:

David Mawdsley
+44 (0) 20 8047 5502
(London)

Stephen Rea
+44 (0) 20 8047 5502
(London)

Sarah Spencer
+44 (0) 20 8047 5502
(London)

David Daley
+44 (0) 20 8047 5502
(London)

US Media enquiries:

Kevin Colgan
+1 919 483 2839
(North Carolina)

Mary Anne Rhyne
+1 919 483 2839
(North Carolina)

Sarah Alspach
+1 919 483 2839
(Washington, DC)

Jennifer Armstrong
+1 919 483 2839
(Philadelphia)

Analyst/Investor enquiries:

Sally Ferguson
+44 (0) 20 8047 5543
(London)

Tom Curry
+ 1 215 751 5419
(Philadelphia)

Gary Davies
+ 44 (0) 20 8047 5503
(London)

Ziba Shamsi
+ 44 (0) 20 8047 3289
(London)

Jeff McLaughlin
+ 1 215 751 7002
(Philadelphia)

Cautionary statement regarding forward-looking statements
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: December 2011

Related Articles

MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) FDA Approval History

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