CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125377Orig1s000

SUMMARY REVIEW

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SIGNATURES PAGE

Patricia Keegan, M.D./s/Patricia Keegan, M.D.Director, Division of Biologic

Oncology ProductsOffce of Oncology Drug Products

STN BL 125377/0 Division Director Summary Review

March 12, 2011Date

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