`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`209803Orig1s000
`209805Orig1s000
`209806Orig1s000
`
`OFFICER/EMPLOYEE LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MEMORANDUM
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`DATE: December 19,2017
`
`TO: Administrative file for NDA 209803
`
`FROM: Liz Godwin, MSHS, CCRP, Regulatory Health Project Manager
`Division of Metabolism and Endocrinology Products, Office of Drug Evaluation II
`
`SUBJECT: Officer/Employee List for NDA 209803
`
`APPLICATION/DRUG: NDA 209803, Steglatro (ertugliflozin) tablets
`
`The following officers or employees of FDA participated in the decision to approve this
`application and consented to be identified:
`
`Aldridge, Allison
`Andraca-Carrera, Eugenio
`Cambon, Alexander
`Ceresa, Carrie
`Chen, Hansong
`Chen, Hepei
`Chen, Xikui
`Cho, Seongeun (Julia)
`Chong, William
`Christodoulou, Danae
`Dinatale, Miriam
`Englund, Erika
`Godwin, Elizabeth
`Griffiths, LaShawn
`Hawes, Jessica
`Khurana, Manoj
`Kleppinger, Cynthia
`LaCivita, Cynthia
`Lalmansingh, Anika
`Li, Fang
`Lin, Karl
`Luong, Elise
`
`
`
`
`
`
`
`
`Mehta, Hina
`Ogbonna, Casmir
`Pohlman, Janice
`Pucino , Frank
`Ramachandra,Meena
`Ryan, Brian
`Sista, Sury
`Thanh Hai, Mary
`Tran, Suong
`Wang, Yun
`Wange, Ronald
`Williams, Sharon
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MEMORANDUM
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`DATE: December 19,2017
`
`TO: Administrative file for NDA 209805
`
`FROM: Liz Godwin, MSHS, CCRP, Regulatory Health Project Manager
`Division of Metabolism and Endocrinology Products, Office of Drug Evaluation II
`
`SUBJECT: Officer/Employee List for NDA 209805
`
`APPLICATION/DRUG: NDA 209805, Steglujan (ertugliflozin and sitagliptin) tablets
`
`The following officers or employees of FDA participated in the decision to approve this
`application and consented to be identified:
`
`Cambon, Alexander
`Ceresa, Carrie
`Chong, William
`Christodoulou, Danae
`Dinatale, Miriam
`Englund, Erika
`Furness, Scott
`Ghosh, Krishnakali
`Godwin, Elizabeth
`Griffiths, LaShawn
`Hawes, Jessica
`He, Lei
`Kasliwal, Ravindra
`Khurana, Manoj
`Kleppinger, Cynthia
`Lalmansingh, Anika
`Mehta, Hina
`Nkah, Shila
`Ogbonna, Casmir
`Pohlman, Janice
`Pucino, Frank
`Ramachandra, Meena
`Rychlik, Idalia
`
`
`
`Reference ID: 4200363
`
`
`
`
`
`
`Thanh Hai, Mary
`Tran, Suong
`Wang, Yun
`Wange, Ronald
`Williams, Sharon
`
`
`
`Reference ID: 4200363
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MEMORANDUM
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`DATE: December 19,2017
`
`TO: Administrative file for NDA 209806
`
`FROM: Liz Godwin, MSHS, CCRP, Regulatory Health Project Manager
`Division of Metabolism and Endocrinology Products, Office of Drug Evaluation II
`
`SUBJECT: Officer/Employee List for NDA 209806
`
`APPLICATION/DRUG: NDA 209806, Segluromet (ertugliflozin and metformin
`hydrochloride) tablets
`
`The following officers or employees of FDA participated in the decision to approve this
`application and consented to be identified:
`
`Cambon , Alexander
`Ceresa, Carrie
`Chong, William
`Christodoulou , Danae
`Dinatale , Miriam
`Englund, Erika
`Godwin, Elizabeth
`Griffiths, LaShawn
`Hawes, Jessica
`He, Lei
`Hu, Yong
`Khurana, Manoj
`Kleppinger, Cynthia
`Lalmansingh , Anika
`Luong, Elise
`Mandula, Haritha
`Mehta, Hina
`Nkah , Shila
`Ogbonna, Casmir
`Paudel, Kalpana
`Pohlman, Janice
`
`
`
`Reference ID: 4200340
`
`
`
`
`
`Pucino, Frank
`Ramachandra, Meena
`Redd, Naomi
`Rychlik, Idalia
`Thanh Hai, Mary
`Tran, Suong
`Wang, Yun
`Wange, Ronald
`Williams, Sharon
`Yang, Hong
`
`
`
`Reference ID: 4200340
`
`