ReportontheDeliberationResults
December2,2016
PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau
MinistryofHealth,LabourandWelfare
BrandNameOtezlaTablets10mg
OtezlaTablets20mg
OtezlaTablets30mg
Non-proprietaryNameApremilast(JAN*)
ApplicantCelgeneK.K.
DateofApplicationMarch24,2016
ResultsofDeliberation
InitsmeetingheldonNovember24,2016,theSecondCommitteeonNewDrugsconcludedthatthe
productmaybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairs
DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.
Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.There-
examinationperiodis8years.Thedrugproductanditsdrugsubstancearebothclassifiedaspowerful
drugs.
ConditionofApproval
Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.
*JapaneseAcceptedName(modifiedINN)
ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe
convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapanese
originalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreference
Englishtranslation.