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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 103234Orig1s5166 STATISTICAL REVIEW(S)

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 103234Orig1s5166

STATISTICAL REVIEW(S)

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 10: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 11: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 12: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 13: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 14: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 15: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 16: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 17: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 18: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 19: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 20: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 21: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 22: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 23: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 24: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 25: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 26: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 27: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 28: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 29: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 30: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 31: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 32: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 33: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 34: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 35: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 36: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 37: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 38: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 39: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 40: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 41: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 42: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 43: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 44: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 45: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 46: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

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Page 48: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 49: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 50: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 51: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 52: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 53: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 54: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 55: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 56: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 57: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 58: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 59: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 60: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

Page 61: CENTER FOR DRUG EVALUATION AND RESEARCH · Revised labeling for Epogen and PROCRIT, including an annotated redline package insert, clean package insert, redline Medication Guide,

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