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1、DRUGREPORT:abacavir.SUMMARY.DrugNameabacavirCompanyGlaxoWellcomeplc(GlaxoSmithKlineplc)HighestDevLaunchedStatusFDAApprovedHivInfection(Adult,Pediatric)TherapyAreasHIVinfectionActionsReversetranscriptaseinhibitorTechnologiesDrugcombination;Oralformulation;
2、Tabletformulation;SmallmoleculetherapeuticTargetReversetranscriptaseUpdatedate18-FEB-2011ReasonforMinorEditorialAmendmentupdate.OVERVIEW.Abacavir(Ziagen)isacytosinenucleosidereversetranscriptaseinhibitor(RTI),developedandlaunchedbyGlaxoSmithKline(GSK)andn
3、owmarketedbyViivHealthcarefollowingthemergerofGlaxoSmithKlineandPfizer'sHIVassetsinOctober2009[1054205].TheproductisindicatedforthetreatmentofHIV-1infection,incombinationwithotherantiretroviraldrugs[481194],[523212]..AbacavirwasfirstlaunchedintheUSinJanua
4、ry1999[324403],[309959],withsubsequentlaunchesintheUKandotherEUcountriesbytheendof2000[363645],[419569].Abacavir300mgwaslaunchedinJapanin1999[1100950];inDecember2004,aonce-dailyformulationofabacavir(ZiagenQD)wasapprovedinJapan[591037],[598492]..GSKhasalso
5、developedandlaunchedafixed-dosecombinationproductoflamivudine+abacavir(Epzicom;Kivexa)andlamivudine+abacavir+zidovudine(Trizivir)..AbacavirhasdemonstratedactivityagainsthepatitisBvirus(HBV)[325947];however,nofurtherdevelopmentwasreportedbythecompanyforthi
6、sindication..InMarch2008,theCHMPannouncedthatitcouldfindnodefinitivelinkbetweenabacavirandanincreasedriskofmyocardialinfarction,ariskidentifiedinD:A:D,along-runningobservationalstudyin33,000HIVpatients.Furtherdatafromongoingepidemiologicalstudieswerereque
7、stedbythecommitteeinordertofurtherassessthispotentialrisk[892172],[892618],[1100416].InApril2009,theCHMPrecommendedprescribersminimizecardiacriskfactorsaftercompletingareviewofD:A:D[1002924].ByMay2009,theFDAwasalsoconductingareviewoftheD:A:Ddataandhadissu
8、edanEarlyCommunicationwarningofthepotentialrisksassociatedwithabacavir[1060760]..2011THOMSONREUTERS.Formoreinformationgotohttp://thomsonpharma.com/copyright/..PATENTANDGENERICSINFORMATIONUSandEUpatentcoverageforabac
