FDA Requires Additional Data on Menveo

As of February 2012, Menveo is registered in more than 50 countries for active immunization to prevent invasive meningococcal disease caused by Neisseria Meningitidis serogroups A, C, W-135 and Y. Menveo received FDA approval for use in adolescents and adults (11 to 55 years of age) in February 2010 and approval for use in children 2 to 10 years of age in January 2011. Since launch, more than 3 million doses of Menveo have been distributed worldwide. Studies are ongoing in infants, toddlers, adolescents and adults.

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Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) on its application for the expanded use of Menveo  in infants and toddlers from 2 months of age. They submitted the supplemental Biologics License Application (sBLA) for Menveo to the FDA in April 2011. The Complete Response letter indicates the FDA has completed the current review cycle and requests answers to additional questions prior to proceeding with further review of the sBLA. Novartis will work with the FDA to address these questions.

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“FDA requests additional data on Novartis quadrivalent meningococcal conjugate vaccine, Menveo®, for expanded use in infants and toddlers.MarketWatch. 13 02 2012  <http://www.marketwatch.com/story/fda-requests-additional-data-on-novartis-quadrivalent-meningococcal-conjugate-vaccine-menveo-for-expanded-use-in-infants-and-toddlers-2012-02-13>.

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