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FDAinvega.pdf

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DepartmentofHealthandHumanServices PublicHealthService FoodandDrugAdministration CenterforDrugEvaluationandResearch OfficeofSurveillanceandEpidemiology DrugUtilizationReview Date:November26,2012 Reviewer:KusumMistry,Pharm.D. DrugUtilizationDataAnalyst DivisionofEpidemiologyII TeamLeaderGraceChai,Pharm.D. DrugUtilizationDataAnalysisTeamLeader DivisionofEpidemiologyII DivisionDirector:JudyStaffa,Ph.D.,R.Ph. DivisionofEpidemiologyII Subject:Invega®(paliperidone)DrugUtilizationReviewforMarch 2013PediatricAdvisoryCommitteeMeeting DrugName(s):Invega®(paliperidone) ApplicationType/Number:NDA21-999 Applicant/sponsor:JanssenPharmaceuticals,Inc. OSERCM#:2012-1744 **ThisdocumentcontainsproprietarydrugusedataobtainedbyFDAundercontract. Thedrugusedata/informationcannotbereleasedtothepublic/non-FDApersonnel withoutcontractorapprovalobtainedthroughtheFDA/CDEROfficeofSurveillanceand Epidemiology.** ReferenceID:3221250 CONTENTS EXECUTIVESUMMARY................................................................................................1 1INTRODUCTION........................................................................................................2 1.1Background............................................................................................................2 1.2ProductInformation...............................................................................................2 2METHODSandMATERIALS.....................................................................................3 2.1DeterminingSettingsofCare.................................................................................3 2.2DataSourcesUsed.................................................................................................3 3RESULTS.....................................................................................................................3 3.1Invega®PrescriptionsinComparisontoRisperidone............................................3 3.2Invega®PrescriptionData.