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Get Product Disposition Form Cd54

Summary Basis for Regulatory Action Date April 29 2010 From Thomas Finn PhD Chair of the Review Committee BLA/ STN 125197/0 Applicant Name Dendreon Corporation Date of Submission Oct 30 2009 PDUFA Goal Date May 1 2010 Proprietary Name Established USAN Name sipuleucel-T Indication is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant hormone refractory prostate cancer.

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