ReportontheDeliberationResults

March3,2021

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameOstabaloSubcutaneousInjectionCart3mg

Non-proprietaryNameAbaloparatideAcetate(JAN*)

ApplicantTeijinPharmaLimited

DateofApplicationMay27,2020

ResultsofDeliberation

InitsmeetingheldonFebruary25,2021,theFirstCommitteeonNewDrugsconcludedthatthe

productmaybeapproved,andthatthisresultshouldbepresentedtothePharmaceuticalAffairs

DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.The

re-examinationperiodis8years.Neitherthedrugproductnoritsdrugsubstanceisclassifiedasa

poisonousdrugorapowerfuldrug.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,the

Japaneseoriginalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthis

referenceEnglishtranslation.

ReviewReport