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Glaxo Receives Complete Response Letter From FDA For Hib-MenCY-TT PDF Print E-mail
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Thursday, 29 September 2011 00:44

GlaxoSmithKline PLC (GSK.LN), a research-based pharmaceutical and healthcare firm, said Friday said it has received a Complete Response letter from the U.S. Food and Drug Administration or FDA for the Biologics License Application for the candidate meningococcal and Hib combination vaccine, MenHibrix or Hib-MenCY-TT.

 

MAIN FACTS:

-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.

-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.
source:GlaxoSmithKline PLC

 
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