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FDA Requests Addl. Data On Novartis' Menveo For Expanded Use In Infants,toddlers

2/13/2012 1:27 AM ET

Novartis (NVS: Quote) said it has received a Complete Response letter from the US Food and Drug Administration or FDA on its application for the expanded use of Menveo in infants and toddlers from 2 months of age.

Novartis submitted the supplemental Biologics License Application or sBLA for Menveo to the FDA in April 2011. The Complete Response letter indicated that the FDA has completed the current review cycle and requests answers to additional questions prior to proceeding with further review of the sBLA. Novartis would work with the FDA to address these questions.

Meningococcal Oligosaccharide Diphtheria CRM Conjugate Vaccine, Menveo, is already approved for use in individuals 2 to 55 years of age in the U.S.

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by RTT Staff Writer

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