ReportontheDeliberationResults

September7,2021

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameMoizertoOintment0.3%

MoizertoOintment1%

Non-proprietaryNameDifamilast(JAN*)

ApplicantOtsukaPharmaceuticalCo.,Ltd.

DateofApplicationSeptember28,2020

ResultsofDeliberation

InitsmeetingheldonAugust30,2021,theFirstCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.The

re-examinationperiodis8years.Thedrugsubstanceisclassifiedasapowerfuldrug.Thedrug

productisnotclassifiedasapoisonousdrugorapowerfuldrug.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,the

Japaneseoriginalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthis

referenceEnglishtranslation.

ReviewReport