原创力文档- 1、本文档被系统程序自动判定探测到侵权嫌疑，本站暂时做下架处理。
- 2、如果您确认为侵权，可联系本站左侧在线QQ客服请求删除。我们会保证在24小时内做出处理，应急电话：400-050-0827。
- 3、此文档由网友上传，因疑似侵权的原因，本站不提供该文档下载，只提供部分内容试读。如果您是出版社/作者，看到后可认领文档，您也可以联系本站进行批量认领。
CENTERFORDRUGEVALUATIONAND
RESEARCH
APPLICATIONNUMBER:
205266Orig1s000
MEDICALREVIEW(S)
AddendumtoClinicalReview
DeniseCasey
NDA205266
Odomzo®(sonidegib)
ADDENDUMTOCLINICALREVIEW
ApplicationTypeNDA
ApplicationNumber(s)205266
PriorityorStandardStandard
SubmitDate(s)September26,2014
ReceivedDate(s)September26,2014
PDUFAGoalDateSeptember26,2015
Division/OfficeDOP2/OHOP
ReviewerName(s)DeniseCasey
AddendumCompletionDateJuly22,2015
EstablishedNameSonidegib
(Proposed)TradeNameOdomzo
TherapeuticClassHedgehogInhibitor
ApplicantNovartisPharmaceuticals
Corporation
Formulation(s)200mgcapsules
DosingRegimen200mgoncedaily
Indication(s)BasalCellCarcinoma
IntendedPopulation(s)Adultpatientswith
advancedbasalcell
carcinoma(BCC)
1
ReferenceID:3796270
AddendumtoClinicalReview
DeniseCasey
NDA205266
Odomzo®(sonidegib)
LabelingRecommendations
Thisreviewwillfocusonhigh-levellabelingrecommendations.TheApplicantsubmitted
anupdatedlabelingproposalwiththe120-daysafetyupdateo
文档评论（0）