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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125293 OTHER ACTION LETTERS

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 125293

OTHER ACTION LETTERS

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

(b) (4)

Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

(b) (4)

(b) (4)

(b) (4)

Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

(b) (4)

Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot
Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot
Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

(b) (4)

Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot
Page 10: CENTER FOR DRUG EVALUATION AND RESEARCH · establish the safety and efficacy profile of pegloticase. Products manufactured with the two processes differ in terms of and we cannot

42 Pages of Draft Labeling has been withheld in full immediately following this page as B4 (CCI/TS)

BLA 125293/0Page 9

Enclosures:Appendix A: REMS TemplateAppendix B: Supporting DocumentPackage Insert Label

Clean CopyTrack-changes Copy


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