MenHibrix
Generic name: Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Disease Prophylaxis
Complete Response Letter for MenHibrix
Regulatory Update: GlaxoSmithKline Receives Complete Response Letter from FDA for MenHibrix 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.
GlaxoSmithKline Enquiries:
UK Media enquiries: David Mawdsley (020) 8047 5502
Stephen Rea (020) 8047 5502
Sarah Spencer (020) 8047 5502
Janet Morgan (020) 8047 5502
David Daley (020) 8047 5502
US Media enquiries: Nancy Pekarek (919) 483 2839
Mary Anne Rhyne (919) 483 2839
Kevin Colgan (919) 483 2839
Sarah Alspach (919) 483 2839
Jen Armstrong (919) 483 2839
European Analyst/Investor enquiries: Sally Ferguson (020) 8047 5543
Gary Davies (020) 8047 5503
Ziba Shamsi (020) 8047 3289
US Analyst/Investor enquiries: Tom Curry (215) 751 5419
Jeff McLaughlin (215) 751 7002
GlaxoSmithKline 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: September 2011
Related articles
- GSK Receives FDA Approval for MenHibrix - June 15, 2012
- Regulatory Update: Glaxosmithkline Submits Additional Information for Candidate Meningococcal and Hib Combination Vaccine - December 1, 2011
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
