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Sanofi SA to Resubmit Lemtrada application for FDA review


Monday, 7 Apr 2014 01:15am EDT 

Sanofi SA:Announced that following constructive discussions with the U.S. Food and Drug Administration (FDA).Company plans to resubmit in the second quarter its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.The resubmission will provide information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. 

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