CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by...
40
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 103234Orig1s5166 SUMMARY REVIEW
Transcript of CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by...
![Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: 103234Orig1s5166
SUMMARY REVIEW
![Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/2.jpg)
![Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/3.jpg)
![Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/4.jpg)
![Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/5.jpg)
![Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/6.jpg)
![Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/7.jpg)
![Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/8.jpg)
![Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/9.jpg)
![Page 10: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/10.jpg)
![Page 11: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/11.jpg)
![Page 12: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/12.jpg)
![Page 13: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/13.jpg)
![Page 14: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/14.jpg)
![Page 15: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/15.jpg)
![Page 16: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/16.jpg)
![Page 17: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/17.jpg)
![Page 18: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/18.jpg)
![Page 19: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/19.jpg)
![Page 20: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/20.jpg)
![Page 21: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/21.jpg)
![Page 22: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/22.jpg)
![Page 23: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/23.jpg)
![Page 24: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/24.jpg)
![Page 25: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/25.jpg)
![Page 26: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/26.jpg)
![Page 27: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/27.jpg)
![Page 28: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/28.jpg)
![Page 29: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/29.jpg)
![Page 30: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/30.jpg)
![Page 31: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/31.jpg)
![Page 32: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/32.jpg)
![Page 33: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/33.jpg)
![Page 34: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/34.jpg)
![Page 35: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/35.jpg)
![Page 36: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/36.jpg)
![Page 37: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/37.jpg)
![Page 38: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/38.jpg)
![Page 39: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/39.jpg)
![Page 40: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:](https://reader034.fdocuments.us/reader034/viewer/2022051915/60073a5d074cd3561555ec08/html5/thumbnails/40.jpg)