ReportontheDeliberationResults

March15,2013

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]NouriastTablets20mg

[Non-proprietaryname]Istradefylline(JAN*)

[Applicant]KyowaHakkoKirinCo.,Ltd.

[Dateofapplication]March30,2012

[Resultsofdeliberation]

InthemeetingheldonMarch8,2013,theFirstCommitteeonNewDrugsconcludedthattheproductmay

beapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct,there-examination

periodis8years,andneitherthedrugsubstancenorthedrugproductisclassifiedasapoisonousdrugora

powerfuldrug.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienceforusers.Inthe

eventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.ThePMDAwillnotbe

responsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

ReviewReport

February22,2013

PharmaceuticalsandMedicalDevicesAgency

TheresultsofaregulatoryreviewconductedbythePharmaceuticalsandMedicalDevicesAgencyonthe

followingpharma