托伐普坦（Tolvaptan）片的CTD资料（PMDA）.pdfVIP

ReportontheDeliberationResults

March3,2014

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname](a)SamscaTablets7.5mg

(b)SamscaTablets15mg

(c)SamscaTablets30mg

[Non-proprietaryname]Tolvaptan(JAN*)

[Nameofapplicant]OtsukaPharmaceuticalCo.,Ltd.

[Dateofapplication]May30,2013

[Resultsofdeliberation]

InthemeetingheldonFebruary24,2014,theFirstCommitteeonNewDrugsconcludedthatapplications

forpartialchangesforSamscaTablets7.5mgand15mgandanewdrugapplicationforSamscaTablets30

mgmaybeapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

SinceSamscahasbeendesignatedasanorphandrugfortheindicationofautosomaldominantpolycystic

kidneydisease,itsre-examinationperiodis10yearsfortheindicationandthedosageandadministration

proposedinthecurrentapplication.WithrespecttoSamscaTablets30mg,thedrugproductisclassifiedas

apowerfuldrug,andtheproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.

[Conditionsforapproval]

(a)and(b)tobeusedforslowingtheprogressionofautosomaldominantpolycystickidneydiseasein

patientswithanincreasedkidneyvolumeandarapidrateofkidneyvolumeincrease,

Theapplicantisrequiredto:

1.TakenecessarymeasurespriortomarketingtoensurethatSamscaisprescribedonlybyphysician