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(AFX UK Focus) 2009-11-18 21:29
BRIEF-Genentech and Biogen get FDA complete response for Rituxan in chronic lymphocytic leukemia
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Nov 18 (Reuters) - Biogen Idec Inc:

  • GENENTECH AND BIOGEN IDEC RECEIVE A COMPLETE RESPONSE FROM THE FDA FOR
    Rituxan for chronic lymphocytic leukemia

  • SAYS IT AND GENENTECH WILL CONTINUE FINAL LABEL DISCUSSIONS WITH THE FDA

  • SAYS FDA HAS NOT REQUESTED ANY NEW DATA TO COMPLETE ITS REVIEW OF THESE
    applications

  • SAYS COMMITTED TO MAKING RITUXAN IN COMBINATION WITH FC AN FDA-APPROVED
    option for people with CLL

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