The FINANCIAL -- Novartis has received a Complete Response letter from the US Food and Drug Administration on its application for the expanded use of Menveo in infants and toddlers from 2 months of age. According to Novartis AG ,Menveo is already approved for use in individuals 2 to 55 years of age in the US.

Novartis submitted the supplemental Biologics License Application 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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