208253orig1s000€¦ · the applicant claims that, based on the provided data (previously obtained...
TRANSCRIPT
![Page 1: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
208253Orig1s000
CHEMISTRY REVIEW(S)
![Page 2: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/2.jpg)
![Page 3: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/3.jpg)
![Page 4: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/4.jpg)
![Page 5: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/5.jpg)
![Page 6: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/6.jpg)
![Page 7: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/7.jpg)
![Page 8: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/8.jpg)
![Page 9: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/9.jpg)
![Page 10: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/10.jpg)
![Page 11: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/11.jpg)
![Page 12: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/12.jpg)
![Page 13: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/13.jpg)
![Page 14: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/14.jpg)
![Page 15: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/15.jpg)
![Page 16: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/16.jpg)
![Page 17: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/17.jpg)
![Page 18: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/18.jpg)
![Page 19: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/19.jpg)
![Page 20: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/20.jpg)
![Page 21: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/21.jpg)
![Page 22: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/22.jpg)
![Page 23: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/23.jpg)
![Page 24: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/24.jpg)
![Page 25: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/25.jpg)
![Page 26: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/26.jpg)
![Page 27: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/27.jpg)
![Page 28: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/28.jpg)
![Page 29: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/29.jpg)
![Page 30: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),](https://reader034.vdocuments.mx/reader034/viewer/2022050212/5f5ee0e6039c802a322106f3/html5/thumbnails/30.jpg)
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
NICOLA M FENTY-STEWART09/11/2015
Reference ID: 3818558