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News Breaks
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February 13, 2012
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| 06:38 EDT |  | NVS |
| theflyonthewall.com: | Novartis: FDA requests additional data on Menveo for expanded use in children | | Novartis has received a Complete Response letter from the U.S. FFA on its application for the expanded use of Menveo, or Meningococcal Groups A, C, Y and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, in infants and toddlers from 2 months of age. Menveo is already approved for use in individuals 2 to 55 years of age in the U.S.. Novartis submitted the supplemental Biologics License Application, or 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. :theflyonthewall.com |
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May 21, 2012
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| 07:38 EDT |  | NVS |
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May 18, 2012
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| 13:34 EDT | | NVS |
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May 17, 2012
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| 05:01 EDT | | NVS |
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