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.
-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.