I-Symbicort yokuqala entsha evunywe ngabenzi bawo yi-US FDA

Namhlanje, i-US Food and Drug Administration ivume i-generic yokuqala ye-Symbicort (budesonide kunye ne-formoterol fumarate dihydrate) I-Inhalation Aerosol yonyango lwezifo ezimbini eziqhelekileyo zempilo ye-pulmonary: i-asthma kwizigulane ezineminyaka emithandathu ubudala nangaphezulu; kunye nokugcinwa kwonyango lokuphazamiseka kokuhamba komoya kunye nokunciphisa ukunyuka kwezigulane ezinezifo ezingapheliyo ze-pulmonary (COPD), kuquka i-bronchitis engapheliyo kunye / okanye i-emphysema. Le mveliso indibaniselwano yeyeza elenziwe ngabenzi balo elinzima, eyimitha yedosi yokuphefumla, akufuneki isetyenziswe ukunyanga uhlaselo lombefu oluqatha.

“Namhlanje ukuvunywa kweyeza lokuqala leemveliso zamayeza awenziwe afana nalawo awenziwe afana nalawo aveliswe ngabenzi enye yezona mveliso zixhaphakileyo zimiselweyo zokunyanga isifo sombefu kunye neCOPD lelinye inyathelo eliya phambili ekuzibopheleleni kwethu ekuziseni iikopi zamachiza antsonkothileyo emarikeni, anokuphucula umgangatho wobomi kwaye ukunceda ukunciphisa iindleko zonyango,” watsho uSally Choe, Ph.D., umlawuli weOfisi yeZiyobisi eziGeneric kwiZiko leFDA loVavanyo lweZiyobisi noPhando. "Oku kubonisa iinzame eziqhubekayo ze-FDA zokunyusa ukhuphiswano kunye nokufikelela kumayeza asemgangathweni, akhuselekileyo, asebenzayo nafikelelekayo kwizigulana nakubathengi."

Isifo sombefu sichaphazela abantu abazizigidi ezingama-25, ngaphezulu kwezigidi ezihlanu kubo ngabantwana, ngelixa iCOPD ibetha ngaphezulu kwe-16 yezigidi, ngokweNational Heart, Lung, kunye neGazi Institute. Umbefu yimeko engapheliyo, yexesha elide echaphazela iindlela zomoya emiphungeni, enokuthi yenziwe mandundu kukwenza umthambo kwaye kaninzi iqala ebuntwaneni. Inokubangela ukuphefumla (isandi sokubetha umlozi xa uphefumla), ukuphelelwa ngumphefumlo, kunye nokukhohlela. I-COPD, equka i-emphysema kunye ne-bronchitis engapheliyo, sisifo sexesha elide, esingapheliyo esibangela ukuvaleka komoya kwaye kwenza kube nzima ukuphefumla.

Le mveliso yendibaniselwano yesixhobo seziyobisi yi-metered-dose inhaler (MDI), equlethe zombini ibudesonide (i-corticosteroid enciphisa ukudumba) kunye ne-formoterol (i-bronchodilator esebenza ixesha elide ekhulula izihlunu kwimizila yomoya ukuphucula ukuphefumla). Ukuphefumla kabini, kabini ngemini (ngokuqhelekileyo kusasa nasebusuku, malunga neeyure ezili-12 ngokuhlukana), phatha izifo zombini ngokuthintela iimpawu, ezifana nokuphefumla kwabo banesifo sombefu, nangokunceda ngokuphefumla ngcono, kwabo baneCOPD. I-inhaler ivunyiwe kumandla amabini (160 / 4.5 mcg / actuation kunye ne-80 / 4.5 mcg / actuation).

Ezona ziphumo bezingalindelekanga zixhaphakileyo ezinxulumene ne-budesonide kunye ne-formoterol fumarate dihydrate oral inhalation aerosol kwabo banesifo sesifuba yi-nasopharyngitis (ukudumba kweempumlo kunye nomqolo womqala), intloko ebuhlungu, usulelo lwendlela yokuphefumula ephezulu, i-pharyngolaryngeal (impumlo nomlomo) intlungu, sinusitis, umkhuhlane. , intlungu yomqolo, ukuxinana kweempumlo, ukungahambi kakuhle kwesisu, ukuhlanza, kunye ne-candidiasis yomlomo (i-thrush). Kulabo abaneCOPD, iziphumo ezichaphazelekayo eziqhelekileyo ziyi-nasopharyngitis, i-candidiasis yomlomo, i-bronchitis, i-sinusitis, kunye nosulelo lwendlela yokuphefumula ephezulu.

I-FDA ihlala ithatha amanyathelo okunceda ukukhokela ishishini ngenkqubo yophuhliso lweemveliso zamachiza enziwe afana nalawo aveliswe ngabenzi, kubandakanywa iimveliso ezidityanisiweyo, ezifana nee-MDIs, ezibandakanya ichiza kunye nesixhobo. Ukuqhubela phambili ukuququzelela uphuhliso lwamachiza enziwe afana nalawo aveliswe ngabenzi, kunye nokunceda ishishini lamayeza enziwe afana nalawo aveliswe ngabenzi kule nkqubo, i-FDA ipapasha izikhokelo ezingqamene nemveliso (PSGs) ichaza ukucinga kwangoku kwe-arhente kunye nolindelo malunga nendlela yokuphuhlisa iimveliso zamachiza enziwe afana nalawo enziwe afana nalawo aveliswe ngabenzi afana nonyango olulingana negama lebhrendi yazo. abalingane. NgoJuni 2015, i-FDA yapapasha i-PSG ye-budesonide kunye ne-formoterol fumarate dihydrate inhalation aerosol.

I-FDA ifuna abaxhasi ukuba bangenise idatha efanelekileyo kunye nolwazi ukubonisa ukuba iimveliso zendibaniselwano yamachiza enziwe afana nalawo enziwe afana nalawo enziwe ngabenzi bokuqala ziyahlangabezana nemigangatho engqongqo yokuvunywa kwe-arhente. Le migangatho iqinisekisa ukuba iimveliso zamachiza enziwe afana nalawo aveliswe ngabenzi bawo zikhuselekile kwaye ziyasebenza njengegama lebhrendi elilingana nemigangatho efanayo yomgangatho ophezulu.

Iimveliso ezintsonkothileyo ziimveliso zonyango apho ukungaqiniseki malunga nendlela yolwamkelo okanye iindlela ezizezinye ezinokwenzeka kuphuhliso lwemveliso zinokuzuza kunxibelelwano lwakwangoko lwezenzululwazi, njengeemveliso ezinezithako ezintsonkothileyo ezisebenzayo kunye neemveliso ezidityanisiweyo zesixhobo samachiza. Kuba iimveliso ezidityanisiweyo zeziyobisi zinokuba ngumceli mngeni kakhulu ekuphuhliseni, zimbalwa ezikhoyo, okukhokelela kukhuphiswano lwentengiso oluncinci. Ukujongana nemicelimngeni enxulumene namayeza enziwe afana nalawo aveliswe ngabenzi antsonkothileyo, kunye nokukhuthaza ukhuphiswano olongezelelekileyo lwamayeza enziwe afana nalawo aveliswe ngabenzi kula mayeza, yinxalenye engundoqo yeSicwangciso sokuSebenza soKhuphiswano lweChiza lwe-FDA, kunye neenzame ze-arhente zokukhuthaza ufikelelo lwezigulane kunye namayeza afikelelekayo.

I-FDA inike imvume yolu hlobo lwe-budesonide kunye ne-formoterol fumarate dihydrate inhalation aerosol kwiMylan Pharmaceuticals, Inc.