Genzyme Receives Complete Response Letter from FDA on Lemtrada (alemtuzumab) Application

31-12-2013 Business Wire HealthComments (0)

GenzymeLemtradaPharmaceutical

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A Complete Response Letter informs companies that an application is not ready for approval. FDA has taken the position that Genzyme has not su

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