广东药学院《药学快讯》

/目录TOC\*ＭＥＲGEFORMAＴ【医药进展】 PＡGEREF_Tｏc24２8６７2６2\h1美国FDＡ批准一种治疗银屑病新药Sｔelara（ustekinumab) ＰAGEREF＿Ｔoｃ2428６７263\h１美国FDA批准第一种治疗周围T细胞淋巴瘤(PＴCL)新药Foloｔyn（ｐralatreｘatｅ） PAGEＲEF＿Toc242８６7264＼h1美国FＤA批准Sabｒil用于婴儿抽搐及癫痫发作 PAGEＲEF_Toc2４２867２６５\h２美国FDA批准Saphriｓ用于治疗精神分裂症与躁狂症（双相障碍）ﻩPAGＥＲEＦ＿Ｔoc２４２867266\h3美国FDA批准一种新降胆固醇药物Liｖalo（pitavastａtin） ＰAGＥREF＿Ｔｏc２42８67２６7\h4美国FDA批准一种治疗II型糖尿病新药Oｎｇlyza(saxａgliｐｔin） ４２86726８\h5美国批准秋水仙碱药Ｃｏlcrys用于治疗急性痛风和地中海热 ＰＡGEREF_Toc24286７269＼ｈ6美国ＦDA批准200９-2010年季节性流感疫苗ﻩ７美国FDＡ批准阿片类镇痛药Onｓｏｌis用于癌症患者 PAGＥRＥF_Toc2４２８６727１\h8美国FＤA批准Efｆient(ｐｒasugreｌ）片剂用于血管成形术病人 PＡGＥREＦ_Toc2４２867272\ｈ9美国FＤA批准第一种用于晚期或转移性肺癌患者的维持治疗药物Ａlimta(pemetrexed) PＡGEＲEF_Toc242８67273\h1０美国ＦＤＡ批准Multａq（dronedａronｅ）片剂用于治疗心率失常ﻩPAＧEREＦ_Toc２4286７274＼h11美国FＤA批准一种通用名版紧急避孕处方药用于17岁及以下少女 PAGＥREF_Toc2４2867２75\ｈ11美国FDＡ批准布洛芬（Ibupｒoｆen）注射剂CaldolｏrﻩPAGＥREF_Tｏc２42８6７276\h1２【政策法规】 PAＧEREF_Toc242８6７2７７＼h１39部门联合发出通知要求加强食品添加剂监督管理工作ﻩＰAＧＥREF_Ｔoc２42867278＼h13关于印发加强基本药物质量监督管理规定的通知 ＰAGEＲEF_Tｏc２4２86７27９\h13国家食品药品监督管理局要求暂停销售使用标示为多多药业有限公司双黄连注射液ﻩＰAGEREＦ_Toc24２８6728０\h１5国家食品药品监督管理局要求加强甲型H1N1流感疫苗安全监管工作 ＰＡGEREF＿Toｃ2４2８6728１\h15国家食品药品监督管理局印发含辅酶Q10和含大豆异黄酮保健食品产品注册申报与审评有关规定ﻩＰＡGＥＲＥＦ_Toc２42867２8２\h15药品不良反应信息通报（第２3期）ﻩ３\h16国家食品药品监督管理局修订溴隐亭和二氢麦角隐亭制剂说明书ﻩPＡGERＥF_Toｃ２4２８6728４\h１8国家食品药品监督管理局关于印发药品技术转让注册管理规定的通知 PAGEREＦ_Tｏｃ242８672８5\ｈ１８国家食品药品监督管理局启动流感防控药械督查工作对甲型H1N1流感防控药械生产、经营、储备、使用环节进行核查ﻩPAGERＥF＿Toc２４２8６７286\h19【业界新闻】ﻩPAGEREＦ＿Ｔoc2428672８7\h202008年度ＳFDA药监统计年报ﻩPＡＧEREF_Toc２4286728８＼h20国家基本药物制度工作正式启动ﻩPAＧEＲEF_Toｃ2４２867２89\h2１我国药品注册管理出现新变化ﻩＰAＧEREF＿Toc242８６7２90\h2２2009年9月美国FDA药品审批情况一览表（本月数据截至9月24日)ﻩPＡGＥＲＥＦ_Ｔoc24２867291＼ｈ2５20０９年8月美国FDＡ药品审批情况一览表 PAGＥRＥＦ_Ｔoc242867２92＼ｈ31国家药物安全评价监测中心率先接受美国ＦDAＧＬＰ检查 PＡGEREF_Toｃ２428６７２9３\h36中国药品行政保护ﻩPＡＧEＲEF_Ｔoｃ２42867294\h3６【国外知名药企动态】 ＰAGEＲＥF_Ｔoc2428６７2９5\h38ＲesuｌｔsReporｔedfｏrEｘploratoryPhaｓeIITrialofNexａvarｉｎCombiｎａtioｎｗｉthCｈemｏｔｈeｒaｐｅutiｃAｇentＰaclｉｔaxelforＴrｅaｔmｅｎtofAdｖancｅdBｒeasｔCａnｃer PAGEREＦ_Toc２42867296\h３８葛兰素史克完成对Ｓtｉefel的并购ﻩＰAGＥRＥＦ_Ｔoｃ２４2８６7２97＼h38流感大流行（Ｈ1N1）2009最新消息:来自ＧSK的关于Ｈ1N1佐剂疫苗第一项临床试验的初步结果 PＡＧＥREF_Toc２4２８67298\h39ＢSI－2０1治疗转移性三阴乳腺癌进入IＩI期临床ﻩPAGERＥF_Toc２４2８672９9\ｈ４0一年给药一次的创新药物密固达有效提高绝经后骨质疏松患者对药物治疗的依从性，全面提升骨密度,降低骨质疏松骨折风险 ＰＡGEREF＿Toｃ2428６7300\h4１MerｃkKGａAＳubｍitsAｐplｉcationｆorClａdｒibineTａｂleｔsａsMultｉpleScleroｓｉsTheraｐyinEuropeﻩPAGEＲEF_Toc２42867301\h４2SecondPhaseIIIＳtuｄｙShoｗeｄLｕcentiｓImpｒoｖedViｓiｏnｉnＰaｔientｓwithRetinａｌVｅinOcｃlｕsiｏnﻩPAGEREF_Toｃ242８67302\h４３【专题】ﻩPAGEＲＥF_Toc242８67303\h４３美国FＤA批准4种H1N1流感病毒疫苗ﻩPAＧEREF_Toc２4286730４\h43新华网：美国正式批准4种甲型流感疫苗上市ﻩPAＧERＥF_Tｏc２4２86７305\ｈ44国外有关研究显示:甲型H1N1流感病毒传染期或长达一周 ＰAGEREＦ_Toc２42867３06\h４5国家食品药品监管局批准华兰公司甲型H1Ｎ1流感疫苗注册申请ﻩPAＧEREF_Ｔoc24２867307＼h45国家食品药品监督管理局批准北京科兴甲型H1N1流感疫苗注册申请 ＰAＧEREF＿Tｏc24２８67308\ｈ4５美国FDＡ提醒公众警惕网上有关出售抗H1Ｎ1流感产品的虚假信息 PAＧERＥＦ＿Toc2428673０9\h47图书馆关于定向信息咨询师调整的通知ﻩＰAＧEREF_Toc24286７31０\h４8【医药进展】美国ＦDA批准一种治疗银屑病新药Sｔelａra（ustekiｎｕｍab）FDＡAｐprovｅｓNeｗDruｇｔｏTｒeatPsoriａsｉｓ（Sept．25，20０9）ＴheU.S.FooｄandDrｕgAdministraｔionｔodａyapproｖedＳteｌara（ｕstｅkｉnumab）,abiologicｐroduｃtｆoｒａｄuｌtswhohaveamoｄeｒａtetｏseｖereformofpsorｉａsis。Plaｑuepｓｏriasiｓisanimmuneｓysteｍdｉｓｏrdeｒｔhatrｅｓuｌｔsintｈeｒapidoveｒprｏduｃtionｏfｓkiｎｃells．Aboｕｔ6milliｏnpeopleintｈeUｎiteｄSｔateｓhａvepｌaquｅpsorｉasiswｈichisｃｈaｒacterizeｄｂythickenedpatchesｏｆｉｎflaｍed，rｅdsｋｉn，oｆｔencovereｄwｉthsilvｅryscａｌes.“Thisappｒovalｐroｖｉｄesａnalternaｔivetｒeatmeｎｔforｐeoplewiｔhplaquｅpsoriaｓis，whｉchｃancausｅsｉgｎiｆicａｎtｐｈysｉcaｌdｉｓcｏmfoｒtｆrompａinanditｃｈingandｒｅsuｌtｉnpoorｓelf-ｉmaｇeforｐeoplewhoareｓelf－ｃoｎscｉoｕｓaboutthｅｉrapｐeａranｃe,”saidJulieBeｉtｚ,M。D．，dｉrｅctｏｒ,OfficeofDrugEｖalｕatｉｏnＩII,inｔheＦDＡ'sCeｎterforDruｇEvaluaｔｉoｎａnｄResｅarch.Stelaｒａｉsamonoclonａlanｔｉｂody,ａlａbｏｒａtory—producedmolecｕlｅthatmiｍiｃｓtｈeｂoｄy'soｗnanｔibodiｅｓthataｒepｒoducedaspartoｆtheiｍmunesystem．Thebiologiｃtrｅatｓpsoｒiasｉsbyblｏｃkingthｅａctionｏftwｏｐｒoｔｅｉnsｗhichｃontrｉbutｅtotｈeoｖerproducｔiｏｎoｆskincｅllsandinｆlammatｉon。Thrｅｅｓtudieｓoｆ２，２66patientｓevａｌuatedｔhebiologｉc’ssafｅtyaｎdｅfｆｅｃtiveneｓs.SinｃｅStelarａreduｃesthｅimmunesyｓtem’sabｉlitytofighｔinfｅctions,tｈeｐrｏductposｅｓariskofinfection。Sｅriousinfｅctioｎshavebeenｒeportｅdinpａtienｔsｒeceiｖingｔheproｄｕctaｎdsomeofthemhaｖeleａｄtoｈospitalizatioｎ。Ｔｈeseiｎｆｅcｔｉonsweｒecａusedｂyvｉruseｓ，fungi，ｏrｂaｃtｅrｉａthatｈavespreadtｈrouｇhoutthebody.Theｒemayaｌsｏbeaｎincrｅasedriskｏfdevelｏpｉｎｇcancer．TｈｅFDAisrequiｒｉnｇariｓkｅvaluatiｏnandmｉtｉgatiｏnstｒategyorＲEMSｆorSteｌａrathaｔｉnｃlｕdeｓacommuｎicationpｌanｔaｒｇetedtｏheaｌthcａreprｏviderｓandameｄicａtionｇuideforpatients.SｔelａraismａnufａcturedbyＣentｏcｏrOrtｈoBiotechInc。ofHoｒｓham，Pａ。，aｗholly－ownedsubsiｄｉarｙｏfJohnsoｎ＆JｏhnsｏnｏｆNeｗBrｕnswicｋ(）美国FDA批准第一种治疗周围Ｔ细胞淋巴瘤（ＰTCL)新药Ｆoloｔｙn(pｒａlａtreｘate)ＦDＡApｐｒoveｓFｉｒsｔＤrugｆorTｒｅatmentofPｅrｉpheralT—ｃeｌlLymｐｈｏma（Sｅpt。25，2009）ＴheU.S．FoodandDrｕgＡdｍｉnisｔｒatｉｏnｈａｓapｐrovｅdFoloｔyn(praｌatrexate),thefｉｒｓttreatmｅｎtｆoｒaformｏfcａｎceｒknownaｓPeriphｅralT—ceｌlLyｍｐhoｍa(PＴCL），anoｆtｅnagｇｒｅssiｖｅｔyｐeofnoｎ—Hodｇkiｎslymphoｍa。ＦｏlｏtyｎwａsapproveｄｕndｅrｔheFＤＡ’saccｅlｅrａtｅｄａcｅsｓ，ｗhichａlｌoｗseａｒｌierａpprovａlｏfdｒuｇstｈaｔmｅetｕnmetmeｄicalneｅds.Ｉtisappｒoveｄｆorpatｉｅntsｗhohaverｅｌapｓed,oｒhａvenotrespｏndedｗelltｏｏｔｈerforｍsoｆcheｍoｔheraｐy.Ｌymphｏmaiｓacancerofｔｈelympｈaｔicｓysｔem，whｉchisｐarｔoftｈeimmunｅsystem．Tｈerｅaremanyｔｙｐesoｆlymｐhoma：ｏnｅtｙpｅiscalleｄHodgｋiｎ’sｄiseaｓe,ａｎdtheｒeｓtarｅcａlｌednｏn-Hｏdgkin'ｓｌｙmphomas．PTCＬｉnvｏｌｖesａtypｅoｆwｈｉteｂｌｏodcｅllcalledT－cｅlｌs.Ｉtisarｅlativeｌyrarediseasｅ,occurringinlessｔhan9，500ｐａｔｉｅntseachyearｉnｔｈeＵｎitedＳtatｅs.“Ｆｏlｏtyn'sapprovａlｄｅmonstratｅｓＦDA＇scomｍitｍｅｎｔtｏtherａpidａｐprovalofｄrugsforｒａreａnｄｕncｏmmｏｎｄiｓeasｅs，”saiｄRicｈaｒdPaｚdur，M。D。,direcｔoroｆtheOffｉceｏｆOncoｌogyDｒugProｄucｔsintheＦDA'sＣenterfｏｒＤruｇEvaｌuationanｄResearcｈ。Ｗhensｔudｙｉnganewｄrｕg,ｉtcantａkｅtｉｍｅtｏlearnwhetheradrugacｔuａllypｒoｖｉdesreａｌimprovementｆｏrpatientｓ–suchａsｌivingloｎgｅｒoｒfeeｌinｇbetｔeｒ。Thｉｓreaｌimpｒｏvｅmｅｎｔｉｓknownａsa“cliｎｉcａlｏuｔｃomｅ．”In1992FDAｉｎstitutedacceleratedapproｖａlｓｗｈichallowearｌieｒａppｒovaｌofdｒugｓbasｅdonasｕrrｏｇatｅendpoｉｎｔ，alａboratorymeasurementorphyｓicalsigｎｔｈatcａnｓerveasanｉｎdirectorsｕbsｔituｔｅmeasuｒeｍeｎtｆｏｒclinｉｃaloutcomｅs.InthｅcaseofFoloｔｙn，thｉsmeantｔｈeFDAａpproｖedthedrugbaｓedｏnevｉdenｃｅｔｈatｉtreｄuceｓtumｏrsiｚe,bｅcausetｕｍorｓhrinkａｇeisconsiderｅdreasonａblylikelytopｒｅdictａcliｎｉcalbeｎefitsuchasｅxtendｉｎgthesuｒvivalｏfcancｅｒpａｔiｅnｔs.Tumoｒshrinkａgｅwａsseenｏｎiｍagiｎgscａnsinonesｔｕdy。Of10９paｔientswｉthPTCＬｉｎtheｔriaｌ，27%hadreｄucｔｉｏnintumoｒｓｉze．Tospeｅdtheｄrｕg'savailａｂility,Ｆolotynwasgrantedprioｒityｒeｖiew，enｓurinｇareｖiewwithinsiｘｍonｔhｓraｔherｔｈan10monthｓforａstａnｄarｄｒeｖiew.Thedrugwasalsｏｄesiｇnatｅdasanｏrｐhandrug,ｗhｉcｈprovideｓavａriｅtyofｆinanｃialinｃentiveｓtomａnｕfａcturersｔhatｄｅveｌoｐdrugsforasmalｌnuｍｂerofｐatienｔｓwithａrarｅdisorｄer.TｈｅmoｓｔｃｏmmonaｄvｅrsｅreactiｏnｓseenｗｉthＦolotynwereirｒitationorsoｒeｓoftｈemuｃousmembrａｎeｓｓuchastheｌiｐs，thｅmｏuｔh,andtｈedigeｓｔivetｒａct,lｏｗplatelｅtcellcｏｕntｓ,lowwhｉｔｅbloodcｅｌlcoｕｎts,ｆever,nausｅa，anｄfａｔigue。Ｆolotyncanharmａｆetus。Woｍｅｎshoｕldavoiｄｂecomiｎgpｒegｎａntwhilebｅiｎgtreatedwiｔhthｉsdrugａｎdｐrｅｇnａntwomeｎsｈoulｄbeinｆormｅdofthepoteｎｔialriｓk.PaｔｉenｔstreatedｗithFｏlotynshouｌdtａkefｏlａtｅandvitamｉｎB1２ｓupplｅmenｔｓtｏredｕcemucoｕsmeｍbraneirritａｔiｏn.FolotynismanｕfacturedbyＡｌlosTherａpｅuticｓInc.oｆWesｔｍｉｎsterAsaconditioｎofａcｃelｅratedappｒｏvaｌ,Allｏswilｌｃｏnｄｕcｔstuｄiｅstｏｃonfｉｒmthａttuｍorsｈrinkaｇeactuallydoesｐredictｔhａtpatｉentswiｌllｉvｅlongeｒ.(）美国FDA批准Sabriｌ用于婴儿抽搐及癫痫发作SａｂrｉlＡpproｖeｄbyＦDAtoTreaｔSｐａsmsinInｆａｎｔsａnｄEｐilepticＳeizuｒes（Aug.21,2009）Ｓabril（vigａｂatrｉn）OralSｏｌutionhasbeenappｒovedｂｙtheU。S。FｏｏdandDrｕgAdminisｔratioｎｔoｔreatiｎfａntｉｌespasｍsinchｉｌdｒeｎａges1monthtｏ2years.SabrilｉsthefiｒsｔdruｇinｔheＵnitｅdStateｓappｒovedtotreatｔhedisoｒdｅr,chａraｃteｒｉzedbｙaseｖerｅtypeｏfseizurethatuｓuａllyａppｅarｓinthｅfｉrstｙｅarｏfｌｉfｅ,ｔyｐiｃａllyｂｅtｗｅenａgｅs4monｔhsand8mｏnｔhｓ.Theｄisordercaｎｂeｄeｂiｌｉtaｔｉｎgｂecauseｏftheｆｒequencyoｆdiｆｆiculｔ－tｏ-ｃoｎtroldaｉlｙseizuｒes。Sabrｉｌ（ｖigaｂatrｉｎ)Tabｌetsｈaveｂｅｅnａpｐｒｏvedforaｄultｕseincombinationwitｈotｈｅｒmedｉcaｔionｓｔotｒｅatcoｍplｅxpaｒtialseiｚｕresthathaｖeｎoｔｒespoｎｄｅdａdequaｔｅlyｔopreviｏuｓｄrugtherapiｅｓ．“Ｓeizｕｒesｃancauseimpａiｒeｄnｅｒｖｏussystemfuｎctｉｏnandｒeｄucｅdqualiｔyoflｉfe，"saｉdＲｕsseｌｌKatz，M．D.，direｃｔorｏftheDivisionofＮｅｕｒolｏgyＰrｏductｓａttheＦDＡ’sCeｎterfoｒＤruｇEvaluationａndResearch.“Infａｎtilespasmsinｃhildrenｔhisｙoungaｒeveryseｒiousanｄthiｓaｐpｒovａｌｐroｖｉdesthesｅpａtientｓandｔｈeirparentｓatｒeatmｅntoptｉon．”Inｆantilｅspasmscoｎｓｉstｐrimarilｙofasuｄｄenbｅndingfｏｒｗａrdoｆthｅｂodywithstiffeniｎｇoｆtheａrmsanｄlegs；ｓomechｉlｄrｅnarchtheiｒbackｓastｈeyextendtｈeiｒaｒmsａｎdlegs.Ｓｐａsmsｔeｎｄtoｏccuruponawakeningｏrafterfｅedｉng，andｏftenoccuｒinclustersofupto10０spasｍs。Ｉnｆaｎtｓmayhavedozenｓofｃｌusterｓanｄsｅｖｅralｈundredspasmspｅrdａy．Manｙundｅrｌｙiｎｇdisoｒdｅｒｓ，sｕｃhasｂirｔｈiｎjuｒy，metａbｏlｉcdｉsoｒdeｒs,anｄgenｅticdisoｒdeｒsｃａngiveｒisｅtospasｍs,mａkiｎｇitiｍpoｒtaｎttoｉdeｎtiｆytｈeｕndｅrｌyingcaｕsｅ。Inｓoｍechildreｎ,nocauｓecanbefound．Eｐｉlepsyisaneurｏloｇｉcalcondiｔｉonthatprodｕcesｄistｕrbancesiｎｔheｎoｒｍａlelectｒicaｌfunｃtiｏnsｏｆthebｒａｉn，causingpeopletohaｖereｃuｒringsｅｉｚurｅs.Seｉzureshａppｅnwhenneｒｖecells,orneｕronｓ,iｎthｅbrａinsendｏuｔｔｈeｗｒongｓigｎａlｓ.Pｅoplemayhａvestrａngｅｓeｎsaｔｉｏnsａnｄemotｉonsorｂehaｖeｓtrａngｅly。Tｈeyｍayhaｖeviolｅntｍusｃｌejerkiｎｇ,whichmayｂerepetitive，orｌoseconｓｃｉousｎess。DamａｇetｏvisionｉｓanimporｔantｓafｅtyconcernwitｈtheuseｏｆSａｂriｌ。Thedrugｗillhavｅａboxedｗarniｎgtoalertｈｅaｌthcareｐrofessioｎalｓtothiｓriskoｆaｐrogressivelossｏｆpeｒｉpheralvｉｓionwithpoｔentialｄeｃreaseｉnｖisuａlａcuiｔy。Theｒisｋofvisionｄaｍagｅmａyｉｎcreaｓｅbａｓedonｔhｅdosageanｄｄurａtionoｆｕsｅ,butevｅnｔhelowestｄｏsesofSabrｉlcancaｕｓevｉsｉｏndamaｇe.PｅｒiｏdicvｉsiontestｉngiｓreｑuirｅdｆｏrthｏsｅtａkingSａｂriｌ．Becauseoｆｔherisｋoｆｐeｒmａnentｖiｓｉｏｎｄamage，thedｒugｗillbeavaｉlａbleoｎlyｔhｒouｇｈａrestriｃｔeddiｓｔributioｎpｒoｇram.SａbriｌwasdesｉgnａtｅdasａnorphaｎｄｒugbytｈｅFDAfｏｒuｓｅｉｎｔreaｔｉnｇinｆａｎｔilesｐａsms.Adrugiｓｅliｇibleforoｒphandrugｄeｓｉgnatioｎiｆiｔisiｎtendedtotreａｔadiseａseｏｒconｄitiｏnthａｔafｆectｓｌessthan200，０0０peopleｉｎtheUnｉｔedStates.Oｒphａndrugstatuｓproviｄｅsthecoｍpａnywｉthｆｉnanciaｌincentｉvestｏpromｏtethedeｖelopｍeｎtoｆadruｇtoｔrｅatａrarediｓｅasｅorcｏｎdｉtion.SabrilisｍadebｙＬｕndbｅｃkInc．of，Deerfielｄ()美国FＤA批准Saphris用于治疗精神分裂症与躁狂症（双相障碍)FDAApprovesSaｐhristoTrｅatＳchizoｐhrｅnｉaａndBipolaｒDisorｄer(Aug。14，20０9）ＴheU.Ｓ．FoｏdａnｄDruｇＡｄmｉnistｒaｔionhasapproveｄSaｐhristablｅｔs(aｓｅnaｐine)ｔoｔreaｔaｄｕltsｗithschizoｐhｒenｉa,ａchｒonｉｃ，severeaｎddiｓaｂlingbrａｉnｄisordｅr,aｎdｔotreatbｉpolarIｄｉsorｄeｒｉnaduｌts，ａｓerｉouｓpsychｉatricdiｓorderｔhatcａusesshifｔsiｎaｐｅｒson'sｍｏod,energy，aｎdａbilitｙtofuｎctiｏn.“Ｍeｎtalillnｅｓｓeslikeｓchｉzｏphrｅniaanｄｂipｏlaｒｄｉｓoｒdercanｂedevastａtingtopａtｉentsａndfaｍiｌiｅs，reｑｕirｉnglifeloｎｇtｒeatmentａｎdtheｒaｐｙ，”ｓaidThomasLauｇhren，Ｍ.Ｄ.，diｒectoｒoftheDiｖiｓionofPsycｈiａtrｙＰroduｃtsｉnｔheFDＡ’sCenterfｏｒDrugEvaluatioｎaｎdResearch.“Ｅｆｆeｃtiveｍｅdｉcinesｃanhｅｌppeopｌewithmenｔalillnesｓlivemｏreindｅｐendentｌｉves.”Ｔheｍosｔcoｍmoｎsymｐtoｍsofschｉzophｒeniaiｎcludehearinｇvoiｃeｓ，ｏｒseeｉngtｈiｎgsthａtarｅnｏttherｅ，havingfaｌsebｅlｉｅfｓ(forｅｘａｍｐle,belｉevinｇｔhatotheｒsarecoｎtｒollinｇｔｈoｕｇhｔs,readingmｉnds，ｏrplｏtｔiｎｇｈａｒm），aｎdbeinginappｒｏpriatｅlysuspiciousorpaｒａnoid。Thｅｓeｔhoｕghｔｓmayｂeterrifyｉnｇａｎdcanｃauｓefearfulneｓｓ，witｈdｒawａl，agitatｉｏnｏrviｏlenｃｅ。BipoｌaｒIdｉｓoｒdｅｒｉsａchrｏnｉc，sｅｖere,aｎdreｃurrentpsycｈｉatricdisorderthatcaｕsesａltｅrnaｔingperｉodsofdepressiｏｎandhigh,incｒeasｅdａｃtiｖｉｔyanｄｒesｔlessness,ｒacingthoughts，talkiｎgfasｔ，impuｌｓivebehaviｏr，andaｄecreａsｅdneeｄforｓleｅｐ.Saphrisisｉnａｃlassｏfdrugscalｌｅdatypｉcaｌantｉpsychoticｓ.Allatyｐiｃａlａntipsychotｉcscontａｉnaboｘedｗaｒning，ｔhｅFＤＡ’ｓｓtrongｅstｗarｎing．Thewarninｇalｅrtsｐreｓcribersｔoaｎincrｅasedｒｉsｋｏfdeathassｏciａｔｅdwitｈoff-labelｕseoftheseｄrugstotreatbehａvｉoraｌpｒoblｅmsiｎolｄerpｅｏpｌewithdeｍeｎtia－rｅlａtedpｓyｃhosis(ａbｒａindｉsorｄerthaｔlesｓｅnstｈeabilitｙｔorememｂeｒ，thiｎk，aｎdreasｏｎ).Ｓaphｒisisnotaｐprovedｆorｔheｓｅpａｔientｓ.ThｅeffｉcａcｙofSａphrｉsｉｎtrｅatiｎgscｈiｚophreniaｗasstｕdiedintｈreeshort－termplａcebｏ-controｌlｅdanｄactivｅ—dｒugcontrolleｄclｉnｉcaltｒials．ＩntwｏofthetｒｉalsSapｈrｉｓdｅmonstraｔｅdsuperioreｆficacycｏmparedｔoaｎinａｃｔivepilｌ（plaｃebo）inredｕcingthesymptｏmsｏfｓchizoｐｈrenｉａ.ThｅefｆｉcａcyofSaｐｈrｉsiｎthetrｅａtｍentofｂiｐolａrｄisoｒｄerwasstｕdiedintwoshoｒt－tｅrｍplacebo—conｔｒollｅdandacｔive-drugcｏnｔrolｌedcliｎiｃaltriaｌｓｉnwhichＳaphｒiswasｓｈｏｗntｏbｅsupeｒiｏrtoｐlａcebｏintｒeatingｓｙmptｏｍsofbipolardisorder.ＴhemostcｏｍmonaｄｖersｅrｅacｔioｎsｒeporｔｅdbｙpatiｅntsiｎcliniｃａltrialｓbeiｎgｔreａtedｆorｓchizｏphrｅniawiｔhSaｐhrｉｓweretｈeinａbｉｌitytｏsitstiｌlorrｅmaｉnmotionless(akａthisｉａ)，dｅcrｅａsｅｄoｒalsenｓiｔiｖitｙ(oralhypoesthｅsia）anｄdrowsinｅsｓ（somnolence).ThemostcomｍonadｖersｅrｅaｃtｉoｎｓｒeporteｄbyｐatienｔsinclｉnicaltｒｉaｌsusｉnｇＳaｐhrisｔotreaｔbiｐｏlaｒdisorｄerｗｅrｅdｒowsinｅsｓ，dizzinｅｓｓ，mｏｖｅmeｎｔdisorderｓｏｔｈerthaｎａkathisiaａndweiｇhtｉncrｅａse.SaphｒisiｓmａnuｆacｔuredｂySchering—Plough，Kenｉlworｔｈ（）美国ＦDA批准一种新降胆固醇药物Ｌiｖalo(pitavａstatin)FＤAApｐrovesNｅwＣholesterol—ＬoweringDruｇ（Auｇust3，2009）TｈeU。S.ＦoodanｄＤruｇＡdｍinｉｓtrationtoｄayappｒovｅdtｈe4mｉlligrammaximuｍｄosｅofLｉvaｌo(pitavastａtin）,ａｄrｕgintｅndedtoimpｒoｖｅbloodcholｅstｅrｏllｅｖelsiｎpersonswiｔhelevatedｏｒabnormａlbloｏdcｈoｌｅsteｒollｅvｅls.Liｋeothｅrsｔatins,Livａｌendedｆorpａtiｅｎtswhendietandexeｒciｓefailtolｏｗｅｒtｈeircholestｅｒolleｖels。ＳtaｔinsimprｏｖｅeleｖaｔedｂloodｃｈoｌesterollｅveｌｓprimarｉｌｙｂyｉnhibiｔingalｉvｅrenｚyｍｅcalledHMＧCo—Arｅducｔａse,tｈｕsreducinｇtheliver＇saｂilitｙtomakｅchoｌestｅｒol.＂Elevaｔedorａbnoｒmalｃholesterollevelsareaｓsociatedwiｔhａniｎｃreaｓedrisｋforheartdiseaseandｓｔｒoke,”saｉdＥriｃC。Coｌman，Ｍ．D.,deｐｕtｙdireｃtｏr,DivisｉonofMetaboｌismandEndoｃrinolｏgyＰroｄuctｓ，iｎｔhｅFDA’sCｅｎteｒforDｒugEvａluatｉonanｄRｅsｅarcｈ。“Ｔｏday’sapprovalｏfferspａtｉｅntsａndｔheiｒhｅａltｈcareprofｅssiｏｎａlsanｏｔｈeraltｅｒnatｉvewaytotreaｔhiｇhchoｌesterol。"Livaloｗasａpｐrｏveｄonｔhｅbａsiｓofｆｉveclｉnicaｌtrialscomｐarinｇitsｅfficacyａnｄsafetytothatofｔhｒeeｃurrentｌｙmaｒketｅdｓtatinｓ。TｈemosｔfreｑｕｅｎｔlyreporｔedadｖｅｒsereactiｏnsfroｍtakingＬivａloweremusｃｌepain,baｃｋpaｉn，jｏｉnｔpａinaｎdconstipation。ＬivaloismanｕfacｔuredbyＫowaPhaｒｍaceuｔｉcａlsAmeriｃaIｎc.ofMontgomerｙ（）美国FＤA批准一种治疗IＩ型糖尿病新药Ｏｎｇlyｚa(saxagｌiｐｔin）FＤＡＡppｒｏvｅｓNewDruｇTｒeaｔｍｅｎtfｏrTypｅ２Diabeteｓ(Juｌy３1，2０09）TheU。S.FｏodandDrugAｄｍinisｔrationtｏdayaｐprｏvｅdＯnglyza（saxagliｐtin），aｏnｃe-ｄaｉlytabｌeｔtｏｔrｅatＴyｐe2diaｂetｅsinadults.Theｍedｉcatiｏniｓｉntｅｎdeｄｔｏbeuｓedwithdietanｄexercisｅtocontｒｏｌhiｇhｂｌoｏｄｓugarlevels．Tｈehｏrmonｅinsulinkeｅｐsbloｏｄsugａr（glucose）levelswiｔhinanarｒowrａngｅｉｎpeoplewhｏdon’tｈavｅdiaｂeｔes.ＰeｏpｌeｗithType2diabetesａreｅｉｔherｒｅsisｔanｔｔｏｉnsuｌｉnordoｎoｔproｄuｃeｅｎougｈinｓｕlintomainｔaｉnｎｏrmａlblｏｏdsugaｒlｅvｅlｓ.Ｏｎglyzａisinaｃlａssofdrｕgsｋnownasｄiｐｅptiｄylpeptidase-４（ＤＰP-4)iｎhｉbｉｔｏrswhiｃhstiｍuｌaｔethｅｐancreastomakｅmoreinｓulinafterｅatinｇaｍeaｌ。“Ｋeｅpinｇbｌooｄsugaｒｌevｅlｓｉｎadｅquatｅcoｎtroliｓessenｔialtothegoｏdhｅalｔhoｆtｈｅ24millｉｏｎｐeｏpleｉnthｅUｎitedStateswｉthTyｐe２ｄｉabeteｓ，”saidMaryPaｒks,Ｍ.D.，directｏrｏfthｅDivｉｓｉonoｆMetabｏlismaｎdＥndｏcriｎｏlogyProductsiｎtheFDA’ｓＣenterforDruｇEvaｌuatiｏnaｎdＲeｓearｃh。“Highｂlooｄsugarｌｅveｌscａｎcausｅbｌurｒｙvisｉｏnaｎdexcessiｖeuｒｉnationandevenｔualｌｙresultｉnsuｃhsｅriousconｄｉtiｏｎsaskiｄneｙａndeyｅdiseaｓe．”ＴhｅmoｓtcｏmmonsideeffeｃｔｓｏｂserｖｅdwithＯnglyzaaｒeuｐperresｐiｒaｔorｙtractinfectｉon,ｕrｉnarytractinｆeｃtｉｏn,andheａｄａｃｈe。Otherｓｉdeeｆfectｓincluｄｅaｌleｒgic-ｌｉｋerｅａctionｓｓｕchａsｒaｓhａnｄhｉｖes.ApproｖalofＯnglｙzaｗasｐriｍａｒilybasedｏnｔhｅrｅsultsofeiｇｈtclinｉcａｌtrials.ThｅapplicaｔionsｅeｋｉｎgＦＤＡapproｖａlwassubmitｔedbｅfoｒｅDeceｍｂｅｒ2０0８whentｈｅａｇencｙrecomｍeｎdｅdthaｔmanufacturersofnewdiabetesdrｕgscareｆullydｅsignaｎｄevalｕatｅtheiｒｃlinicａltrialsforcａrdiovasculａrsafeｔｙ。ＡｌthｏuｇhOnｇlyzａwasnoｔaｓsociａtｅdwｉthａｎinｃreasedrｉskｆｏrcａrdiovasculａreventｓinpaｔiｅntsｗhowerｅmaiｎｌｙatlｏwrisｋfortheseｅvents，tｈeＦＤAisreｑuｉrinｇapostmaｒketstudythatwillｓpｅcifiｃallyevalｕatecａrｄiovascｕlaｒsａｆeｔyｉnaｈｉｇｈerｒｉsｋpopuｌation.OnｇlyzaismanufacｔｕｒedbyBriｓｔoｌ—MyersSｑuiｂbCo.oｆPrｉｎceton,N．J．，ａndmarkeｔedbyBｒisｔol-MyeｒsandAｓtrａZenecaPhａrｍaceuｔicalｓLP,ofWｉｌmingtoｎ（）美国批准秋水仙碱药Coｌcｒys用于治疗急性痛风和地中海热FDAAｐprovesＣolchｉcinｅforAcutｅＧｏuｔ,ＭediｔerraneanFeｖer（Jｕly30，20０9）Aｇencyalsoprovidｅsneｗinｆormatioｎtoｐhｙsiｃiansreｇａrｄｉngsafeuseｏｆｄｒug。TｈeU。Ｓ.FoodandDrugAdmｉｎｉsｔrａtionhaｓappｒoｖedColcrystｏtreatacutｅflairsinpaｔiｅntswitｈｇouｔ,arｅcuｒrenｔandｐａinfulforｍoｆarthritis，andpaｔienｔswｉthfaｍiliaｌMediｔeｒｒaneanfever(FMF)，aniｎｈeritedinflammatｏrydiｓoｒder．Tｈeｍeｄicaｔion'saｃtｉveingreｄｉenｔｉsｃolchicine,ａcｏmplexcomｐounｄderiｖedfｒomthｅdrieｄseｅdｓofaplantkｎownａstheautumnｃroｃusormeadｏwsａfｆron（Colchicｕmａutuｍnale)．ColchicineｈasbeenｕsedbyｈeａlｔhcarepractｉtionｅｒｓｆｏrmanyｙearsｔotｒｅatgoutbuthaｄnotbeeｎａｐprovedbyｔhｅFDA.ＴｈｅFＤAｈasaninｉtiａtｉvｅundｅｒwayｔobrｉngunapｐrｏved，ｍａrkｅductsliｋecolchｉｃineuｎｄｅｒitｓregulatoryｆraｍeworｋ．Thｉsiｎｉtｉaｔivepromｏｔesthegoaｌofasｓuｒinｇｔｈatａllｍａrkeｔeddrｕgｓｍeeｔmodernｓtaｎｄarｄｓｆorｓafｅtｙ，eｆfectiveｎesｓ，qｕalityａndlabeling．Ｐｈｙsiｃiａnshisｔorｉcａlｌyｈaveｇivenｃolchｉcinｅｈｏuｒlyｆoｒａcｕtｅgoutｆlaresuntｉlthefｌaresｕbsideｄortheｙhadtｏstｏptｒeatmenｔｂecausethepaｔientbｅganexperｉencｉnggastrｏiｎｔｅｓtinalprｏｂlems。AdｏｓｉngｓtudyrequｉｒedaspaｒtoｆFDAapｐｒｏvaldeｍonstratｅdｔhatｏnedoseinitiａllyandaｓｉnｇleａdditionａｌdoseafteroｎeｈourwaｓjusｔaｓｅｆfecｔiｖeascoｎtiｎuedhoｕrlydoｓｉngforａcutegoutflaｒｅs,ｂutｍuchlesｓtoxic.Ａsaｒesuｌt，thedrugisbeinｇａpｐｒovｅｄfｏｒacutegｏutｆlarｅswiｔhthｅlowｅrｒecommendeｄdosingｒeｇiｍen。ＴｈeFＤＡisａlertｉnｇheaｌｔhcareｐrofｅssiｏnalsｔothisｎewdｏsingreｇimｅnandalsowaｒnｉｎgａboutthepｏtｅntialforsｅvｅrｅdruginｔerａctionｓwhenpａtieｎtstakecolcｈicｉｎe．ＴhemedicｉnalvalueofusｉｎgcolcｈicuｍwasｆirstidｅｎtｉfｉｅdintｈｅfiｒstｃentuｒｙＡ。D.anditsusefoｒtreatingacutegouｔdａtesbａcｋtｏ1８10．Pｈysiciaｎshaveｐrｅｓｃriｂeｄｔｈemeｄicatiｏｎsｉｎcｅtｈen。Althougｈsｉｎglｅ-iｎgredｉentcolｃhiｃinｅhasnotbeｅnaｐproveｄbｙｔｈeＦDAuｎtilnoｗ,ａcｏmbinａductｃonｔainingcolｃhicineandanagenｔtｈａtｉncreasedthｅexcｒetionｏfuriｃaｃｉdintheurｉnewasａpｐrｏvｅdbyｔheFＤＡin1939。FMFｉsthｅｍostｃomｍonｏfthehereditａrｙperiｏdicfｅversyndｒomｅsａndischａracteｒizedbyrecurrｅntｅｐisodｅｓoffevｅr,ａrthｒitisandpaiｎfulinｆlammａtiｏnofthelininglaｙersofｔheｌungsａnｄabdｏmen.TｈougｈrarｅｉntheUnｉtedＳtates，itismｏrecommoninＭediｔｅrrａnｅancouｎtries.ＰhysicianshaveｐｒesｃribedcｏlchiｃiｎefｏrＦＭFformａnyyeaｒsbaｓedonstｕdiesｓhｏｗｉnｇｔhatｉｔreｄucedthｅｆrｅquencyofattacｋsｂutuｓeoｆcoｌｃhiciｎefｏrFＭＦhａdｎｅverｂeenappｒovｅd.Wiｔｈthｉsａpｐrｏval,ColcrｙsbeｃomesthefiｒｓｔdrｕgａpproｖeｄtｏｔｒeatFMF．CoｌｃrysismａnuｆａｃtｕｒedbyＭutｕａlPharmaceuticaｌCompany，Inc.，Philadeｌｐhｉa。（）美国FDA批准2009－20１0年季节性流感疫苗FDAApｐrovesVaｃcinefor20０9－20１0SeａsｏnalInfluenza（Jｕly2０,2０0９)TheU。S.ＦooｄandDｒuｇAdｍinistｒaｔiｏnｔodayannｏｕncedthatitｈasａｐprovｅｄａvaｃｃｉneｆoｒ２009－２0１０ｓeasonaｌiｎｆlueｎzaintｈeＵnitedSｔateｓ。Tｈeseａsonaliｎfｌuｅｎｚavａcｃineｗiｌｌｎotprotecｔagａinsttｈe２００9H１N1iｎfｌｕeｎｚaviｒｕsｔｈａtresultedintｈedeclaratiｏnofaｐaｎｄemicbｙｔhｅWorldHealｔhOrganｉzaｔion(WHO）onJuｎe11,2009．TheFDAcontｉnuｅｓtｏｗorkwiｔｈmanuｆacturｅrs,internａtionａlpartｎeｒsanｄotｈergovernmｅntaｇenciestofａciliｔａｔｅtheavailabiｌityofasａfeandeｆfｅctivｅvaccineaｇaｉｎsｔｔhｅ2０09H1Ｎ1influenzavirus.Alｔｈouｇhtｈisyear’ｓsｅaｓｏnａｌvａcｃｉnｅisdiｒectedagａinstotherstｒaｉnsoｆｉnflueｎzaeｘpｅctｅdtobecirculatｉngａnｄwｉllnotｐrovideprｏtｅｃtiｏnａgainsｔｔhｅ2009Ｈ１N1iｎｆlｕenzavｉrus，ｉtiｓstillｉmporｔantforthｏseＡｍericansforwhomitisｒeｃｏmｍendeｄtoreｃeiveｔheseaｓｏnalｉnfluenzavａｃcinｅ．Noｖａccｉneiｓ100percenｔefｆectiｖeagainstpreｖentingdiｓeａｓｅ,bｕtvacｃiｎatｉonistｈｅbeｓtprotectionａgainsｔiｎflｕｅnzaaｎdcanｐrｅｖeｎtmanyｉlｌnesｓｅｓanddeaths。“Theaｐprovalｏfthiｓｙeａｒ’ssｅaｓonalinflｕｅnｚaｖａccｉneisaｎexaｍpleｏｆtheＦＤA’ｓｉｍportanｔresｐoｎsｉbiｌitytoasｓuｒetimｅｌyavaiｌabilｉtyｏfvａcｃｉｎｅtoheｌpｐroｔｅｃｔｔhｅheａlｔｈoftheAmeriｃaｎpublｉc,”saiｄMａｒgaｒetA.Ｈａmbｕrｇ,Ｍ.D。,cｏmmissｉonerｏｆfｏodanddrｕgｓ.“Ａnewseａsonalinｆｌuenzavacｃiｎeeａcｈyｅarｉｓacriticａltoolｉnproteｃtingpuｂｌichｅaｌｔh."Thesｉxvaccinｅbｒanｄnａmesandmａnｕfacｔurersare:Ａflurｉa，CSLＬimited；Ｆlｕａriｘ,GｌaｘｏSmｉｔhKlｉｎeBiologicals；FluＬaval,IDＢioｍedicａlCoｒpoｒaｔｉon；Fluviｒｉn，NｏvarｔisVacｃinesａndＤiａgnosｔicsLimited;Ｆluｚoｎｅ，SanｏfiPａsteurInc．;aｎdＦluMist，MedIｍmuneＶaccineｓInｃ.Eacｈyear,experｔｓfromtheＦＤA，ＷＨＯ,ＢasｅdonthosｅforeｃａstｓaｎdoｎthｅreｃommｅｎｄaｔionｓoｆtｈeFDA’sVaccineandRelatedProｄuctsAdvｉｓoryＣommiｔtｅe，tｈeFＤAｄeｔeｒminesｔhｅthｒｅestrａinsｔhaｔmanｕｆacturerssｈouｌｄinｃludeiｎｔｈeirvacｃinesｆoｒｔheU．S.population。Ｔheclｏsｅrtheｍatcｈbｅｔweentｈeｃirculatiｎｇstrainsanｄthesｔrａinsｉnthevaｃcine,ｔｈebettertheprotectionagａiｎstthediseａｓｅ.Thｅvaｃcineforthe200９-2010seasonaｌinfluenzａconｔainｓ:anA/Brisbane/59/２0０7(H1N1）－lｉkevｉrｕsaｎA/Brｉsbane／10／2007（H3N2）—ｌｉkｅviruｓaB/Ｂrisbanｅ／6０／2008-likｅｖirusＴherｅisaｌwayｓapossiｂiｌｉtyｏfaleｓｓｔhanoptimａlmａtchbｅtweeｎthevirussｔrainｓprｅｄｉｃtｅdtｏcircｕｌatｅａｎdthｅvirｕsstraｉｎstｈateｎｄuｐｃausinｇtheｍoｓtiｌlness。Evenｉftｈevaｃcｉｎeａｎｄtｈecｉrcｕｌatinｇsｔrainsareｎoｔaｎexaｃtmaｔch,tｈeｖacｃineｍａｙrｅduｃetｈesevｅrityoｆtheillnesｓｏrmayheｌppreｖｅｎtiｎfｌuｅnｚa-ｒｅlateｄcomplicａｔｉons.AｃcordingtｏthｅCDC，between5ｐeｒcｅｎtanｄ20pｅｒcentoftheU。S．pｏｐｕlationdevelopsinfluenzaｅacｈyear。Morｅthaｎ２００,0００arehospｉtaliｚｅｄfｒomitscoｍpliｃatiｏｎsandaｂout36,00０peoｐｌedｉe。Ｏlｄｅrpeoｐle,yｏuｎｇcｈiｌｄren,ａndpｅopleｗｉｔｈchｒｏnicｍedicａlconditiｏｎsarｅaｔhigherriskforiｎfluenzａ－rｅlatedｃｏmplicationｓ．Ｖａcciｎaｔiｏnoｆthｅｓegrｏuｐsiscriｔicaｌ．Ａｄdｉtionaｌlｙ，influｅnzaｉmmunizａtioｎofhｅalthcarｅpｅrsoｎnelisｉmｐortaｎtinprotｅctiｎgthemａndｏthｅｒｓfromｉnflｕｅｎｚa.（)美国FDA批准阿片类镇痛药Ｏnsｏlis用于癌症患者ＦDAＡpproveｓOｐioidＰainRelieverwｉthＲequｉreｄRｉsｋRedｕctｉoｎPｌａn(July16,2009）TheＵ。S。FoｏdanｄＤrugAｄmｉnistratiｏｎtodａyaｐpｒovedOnsolis，ｍｅdｉｃationｉntendedｆorｃｅｒtainpａｔｉenｔswiｔｈcａncertohelpmａnagｅbreａkｔhroughpａｉn–seveｒeflａresofpainｔhatｂreaｋthｒoｕghreｇuｌarｐａiｎmedication．Onsolisiｓiｎaclaｓsofdrｕgｓthatdelｉverthｅpｏtｅntopiｏidfentanylｔｈｒougｈthemouｔh’smucousｍemｂrａnｅｓ．Oｎsoｌiｓdeｌiversfentanyｌviａａnａbsorbabｌefiｌmthａtｓtiｃｋsｔotheinsidｅｏfthecｈeeｋ.Ｔhｅdrｕgisｉndiｃatedforthemaｎａgementｏｆbｒｅakthroｕｇhｐａinｉnpaｔiｅntsｗｉthcaｎｃｅr，ａgeｓ18ａnｄｏｌｄer，wｈoaｌreadyuseｏpｉoidｐaiｎmedｉｃatiｏnaroｕｎdthecloｃkａndwhoｎeedanｄａｒeaｂｌｅtｏsaｆelyｕseｈｉgｈdosesofanadditioｎalｏpioidmedｉcine．Sｕcｈｐatientsａｒeconsidｅredopioidｔoｌeraｎtｂecａｕsｅoftheｉrcurrentｏｐioidmedicａtｉonｕｓe．Beｃａusefeｎtanylissubjecttoaｂuseanｄmｉsuse,OnsoliswasapproveｄwithａRiskEvaluatｉｏnａndMitiｇaｔｉonStrategy，orREＭS，whichiｓarequiredpｌanformaｎａｇiｎｇrｉsksassocｉatｅdwiｔhadrｕgｏrｂｉｏｌoｇicａｌprｏduｃｔ．“Onsoliｓcanpｒovideｓtroｎｇpａiｎreｌｉeftopatientswhoaｒｅoｐｉoidtｏleranｔ.Bｕｔｆorpatientｓwhoarenoｔopioidtｏleranｔ,itcａnlｅadtooveｒdoｓe，sudｄｅnｓeriousｂｒeatｈiｎgdiｆｆicｕｌｔiesandｄeath，"saidBoｂRappapｏrt,Ｍ．Ｄ。,ｄirｅctｏｒ,DivisionoｆAnesｔheｓia，AnaｌｇesiaaｎdRheumatｏlogyPｒoｄｕctsiｎtｈeＦDA'sCenterfｏrDｒｕｇEvａlｕaｔionanｄＲesearch（CDER）.“Forｔhisreaｓon，OnｓoｌisｓhouｌdbｅpresｃrｉｂｅdonｌyundertｈesafeguａrdsｐｒovidｅdbｙｔheFDＡ-reｑuｉrｅｄＲEMSandｂyhealthcａreｐｒｏfessioｎaｌsknｏwleｄｇｅableaｂoｕｔＯnsolisandtheusｅoｆpotenｔopioｉｄmedicatｉons．”ＴｈeＦoodaｎdDrｕｇAdministratioｎAmendmenｔsActof2007gaveｔheFDAtｈeaｕthｏritytoreqｕｉreｔhatdｒugｓaｎdｂiｏｌｏｇiｃaｌｐｒodｕctｓｈaｖeaRＥMＳtoenｓuｒethattheｂenefｉtsｏfadruｇorｂｉologｉcalｐroductoutweighitsｒisks.AspａrtofthｅREMＳ，OnｓoｌisｗｉllonlybeａvａilａblｅｔhrouｇhａrestricｔeddistrｉbｕｔｉonprogramｃalleｄthｅFOCUＳprogｒａｍ．Ｕｎｄｅrｔｈisｐｒogｒam，onｌｙthoｓeｐｒescribeｒs，ｐaｔientsanｄpｈarｍaciesregiｓｔeredwitｈthｅｐrogramwillbｅabｌetoｐrescrｉbe,ｄisｐense，andｒｅcｅiveOｎｓolｉs.TheＦOCUSprogｒamwｉllprovidetｒainｉｎgａndｅduｃａｔioｎalmatｅrialstoｐrescｒibersanｄpharｍacypeｒsonｎel，andacounselingcallwillbeplacedｔopaｔｉentsｐrｉorｔoｄispensingｔoensureｔhｅyhavebeｅnadｅquatelyeｄuｃaｔedａbｏuttheapｐroprｉateuseｏfthｅdｒｕg．Ｐrｅscriptｉonorderｓｗiｌｌbeｆilｌｅｄｏnlybyｐａrtｉcipatingpharmacｉｅsthａtｓendtｈｅｐrｏductdirecｔlytotｈepatieｎts’hoｍｅs。Onｓoｌｉｓwａsapｐrovedwithａboxeｄｗarninｇ,whichｓtaｔｅsthatthemeｄicatｉonｓhouｌdnotbeuｓedforthｅmanaｇemｅntoｆmigraｉnes,dentalpain，orｐostoperaｔivepaiｎｏrbypaｔieｎtswhouｓｅopiｏiｄｓinｔermittｅnｔly,orｏnａnas—ｎeedeｄbａsｉs.Ｉtalsoｗarnsｔｈattｈｅdｒuｇshoｕldbeｋeptouｔofthereachofcｈildrｅnandsｈouldnotbesuｂsｔｉtutｅｄｆｏrotｈｅrfｅntanylprｏdｕｃｔs．InFebruarｙ,theFDAａnnouｎcedthatitwouldrequｉｒeａREMSfｏraｄifferentcｌassoｆopioidsthatｏfferlong—acｔiｎgandexteｎded—rｅleasemedｉcａｔiｏn.TheFＤAｈasheｌｄaserｉesoｆｍeetｉｎgswithstaｋeｈolders，iｎcluｄinｇａlargeｐublicmeeｔing，anｄalｓoｓｏlｉciｔedwriｔteｎpubｌiccｏmmeｎtstoｈearmoreaboｕthowtoｄeveｌopｔhiｓREMS。“TheRＥMＳforＯnｓoliswａsspｅciｆicallytailoｒeｄｔoｔhaｔdrugandshouldnｏtbevｉewedasamoｄｅlRＥMSforlonｇ-actiｎgａｎdextenｄeｄ-ｒeleasｅopioｉｄproduｃtｓ，”sａｉｄＤouglasThrｏckmorton，Ｍ。D.,depｕtydｉｒectorofCDＥR。“DevelｏｐｉｎｇｔｈｅcoｍpreｈeｎsｉvｅＲEMＳｆorthesｅoｔherprｏduｃtｓｉsaｃoｍｐｌｅｘundertａking．Wewiｌｌｔakeｔhｅtiｍeｎecessａrytoｒevieｗallｏfｔｈepubliccｏｍmentsaｎdwillproｃｅeｄiｎaｄeliberａteｍａnｎertｏwardthｅｍutuａlgoalsofｐatientaccessaｎdpａｔeｃtiｏn．”ＯnｓolｉｓiｓｍanufacturedbｙAvｅvaDrugＤeliverｙSystems，Miramａr,Fla。,aｎdmarkｅtｅdundｅrlicenseｆromBi