CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

204767Orig1s000

CHEMISTRY REVIEW(S)

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

YING WANG06/21/2013

PRASAD PERI06/21/2013I concur

Reference ID: 3329610

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

DANAE D CHRISTODOULOU11/27/2012Signing for Danae Christodoulou and Prasad Peri

Reference ID: 3222239