BLA Ipulumab

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 23

CENTER FOR DRUG EVALUATION AND

RESEARCH

APPLICATION NUMBER:

125377Orig1s000

CHEMISTRY REVIEW(S)
(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)
(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)
(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4) (b) (4)


(b) (4)
(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)
(b) (4)

(b) (4)

(b) (4)

(b) (4)
(b) (4)
(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)
(b) (6)

(b) (6)

(b) (6)

(b) (6)

(b) (6)

150 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
(b) (4)
(b) (4)

(b) (4)

(b) (4)
(b) (4)

(b) (4)

(b) (4)
(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)
(b) (4)
(b)
(4)

(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4) (b) (4)

(b) (4)
(b) (4)

(b) (4)
(b) (4)
(b) (4)

(b) (4)
(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)
(b) (4)

(b) (4)

(b) (4)

(b) (4)
§UivIlVIARY:B:LA. 125377 Ipi1mumab

VI. SIGNATURE BLOCK

Name and Title Signature and Date


(b) (6)

Patrick Swann, Ph.D" Deputy Director


Division of Monoclonal Antibodies

Kathleen Clouse, Ph.D., Director, Division


of Monoclonal Antibodies

Barbara ReHahan, MS, PhD


Product Quality Team Leader
Division of Monoclonal Antibodies

Subramanian Muthukkmar, PhD


Product Reviewer
Division of Monoclonal Antibodies

Carla R. Lankford, MD, PhD


Product Reviewer
Division of Monoclonal Antibodies

Page 11 of 11

You might also like