I-Symbicort yokuqala eyijenerikhi entsha egunyazwe yi-US FDA

A BAMBA MahhalaRelease 5 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

Namuhla, i-US Food and Drug Administration igunyaze ijenerikhi yokuqala ye-Symbicort (budesonide kanye ne-formoterol fumarate dihydrate) I-Aerosol Yokuhogela ukuze zelashwe izimo ezimbili ezivamile zempilo yamaphaphu: isifuba somoya ezigulini ezineminyaka eyisithupha nangaphezulu; kanye nokwelashwa kokugcinwa kokuvimbela ukugeleza komoya kanye nokunciphisa ukukhushulwa kweziguli ezinezifo ezingamahlalakhona zokuvimbela i-pulmonary (COPD), okuhlanganisa ukucinana kwemigudu yokuphefumula engapheli kanye/noma i-emphysema. Lo mkhiqizo oyinkimbinkimbi wenhlanganisela yedivayisi yezidakamizwa, okuyi-metered-dose inhaler, akufanele usetshenziselwe ukwelapha ukuhlasela kwesifuba somoya okukhulu.

“Namuhla ukugunyazwa kwejenerikhi yokuqala yomunye wemikhiqizo exubene nezidakamizwa esetshenziswa kakhulu ekwelapheni isifuba somoya kanye neCOPD kungesinye igxathu eliya phambili ekuzibophezeleni kwethu ekuletheni amakhophi emithi ejwayelekile emakethe, engathuthukisa izinga lempilo futhi ukusiza ekwehliseni izindleko zokwelashwa,” kusho uSally Choe, Ph.D., umqondisi weHhovisi Lezidakamizwa Ezijwayelekile eSikhungweni Se-FDA Sokuhlola Nokucwaninga Kwezidakamizwa. "Lokhu kukhombisa imizamo eqhubekayo ye-FDA yokukhulisa ukuncintisana kanye nokufinyelela emithini esezingeni, ephephile, esebenzayo nethengekayo ezigulini nakubathengi."

Isifuba somoya sihlasela abantu abayizigidi ezingu-25, abangaphezu kwezigidi ezinhlanu kubo okungabantwana, kuyilapho i-COPD ihlupha abangaphezu kwezigidi ezingu-16, ngokusho kweNational Heart, Lung, and Blood Institute. Isifuba somoya yisimo esingelapheki, sesikhathi eside esithinta imigudu yokuphefumula emaphashini, engaba yimbi kakhulu ngokuzivivinya ngokomzimba futhi ngokuvamile eqala ebuntwaneni. Kungabangela ukuhefuza (umsindo womlozi lapho uphefumula), ukuphelelwa umoya, nokukhwehlela. I-COPD, ehlanganisa i-emphysema kanye ne-bronchitis engapheli, yisifo sesikhathi eside, esingamahlalakhona esibangela ukuvaleka komoya futhi senze kube nzima ukuphefumula.

Lo mkhiqizo wenhlanganisela yedivayisi yezidakamizwa uyi-metered-dose inhaler (MDI), equkethe kokubili i-budesonide (i-corticosteroid enciphisa ukuvuvukala) kanye ne-formoterol (i-bronchodilator esebenza isikhathi eside ephumuza imisipha emigudwini yomoya ukuze ithuthukise ukuphefumula). Ukuhogela kabili, kabili ngosuku (imvamisa ekuseni nasebusuku, cishe amahora angu-12 ngokushiyana), kwelapha izifo zombili ngokuvimbela izimpawu, njengokuphefumula kulabo abanesifuba somoya, nokusiza ngokuphefumula okungcono, kulabo abaneCOPD. I-inhaler igunyazwe amandla amabili (160/4.5 mcg/actuation kanye ne-80/4.5 mcg/actuation).

Imiphumela evame kakhulu ehlobene ne-budesonide ne-formoterol fumarate dihydrate oral inhalation aerosol kulabo abaphethwe isifuba somoya i-nasopharyngitis (ukuvuvukala kwamacinene nomhlane womphimbo), ikhanda elibuhlungu, ukutheleleka komgudu wokuphefumula ongenhla, i-pharyngolaryngeal (ikhala nomlomo) ubuhlungu, i-sinusitis, umkhuhlane. , ubuhlungu beqolo, ukucinana kwekhala, ukungakhululeki kwesisu, ukuhlanza, kanye ne-candidiasis yomlomo (thrush). Kulabo abaneCOPD, imiphumela emibi evame kakhulu i-nasopharyngitis, i-candidiasis yomlomo, i-bronchitis, i-sinusitis, kanye nokutheleleka kwepheshana eliphezulu lokuphefumula.

I-FDA njalo ithatha izinyathelo zokusiza imboni ngenqubo yokuthuthukiswa kwemikhiqizo yemithi ejwayelekile, okuhlanganisa imikhiqizo eyinhlanganisela, efana nama-MDI, ehlanganisa umuthi nensiza. Ukuze kuqhutshekwe kube lula ukuthuthukiswa kwemithi ejwayelekile, kanye nokusiza imboni yemithi ejwayelekile kule nqubo, i-FDA ishicilela imihlahlandlela eqondene nomkhiqizo (PSGs) echaza ukucabanga kwamanje kwe-ejensi kanye nalokho okulindelwe ukuthi ingasungulwa kanjani imikhiqizo yemithi ejwayelekile elingana ngokwezokwelapha negama lomkhiqizo wabo. ozakwabo. NgoJuni 2015, i-FDA yashicilela i-PSG ye-budesonide ne-formoterol fumarate dihydrate inhalation aerosol.

I-FDA idinga abaxhasi ukuthi bathumele idatha efanele kanye nolwazi ukuze babonise ukuthi imikhiqizo eyinkimbinkimbi yenhlanganisela yezidakamizwa ezijwayelekile ihlangabezana nezindinganiso zokugunyaza eziqinile ze-ejensi. Lawa mazinga aqinisekisa ukuthi imikhiqizo yemithi ejwayelekile iphephile futhi isebenza kahle njengegama lomkhiqizo futhi ihlangabezana namazinga aphezulu afanayo.

Imikhiqizo eyinkimbinkimbi imikhiqizo yezokwelapha lapho ukungaqiniseki mayelana nendlela yokugunyazwa noma ezinye izindlela ezingenzeka zokuthuthukiswa komkhiqizo zingazuza ngokuzibandakanya kwesayensi kwangaphambi kwesikhathi, njengemikhiqizo enezithako ezisebenzayo eziyinkimbinkimbi kanye nenhlanganisela yemikhiqizo yezidakamizwa. Njengoba imikhiqizo ehlanganisiwe yedivayisi yezidakamizwa ingaba inselele kakhulu ukuyithuthukisa, imbalwa ekhona, okuholela ekuncintisaneni kwezimakethe. Ukubhekana nezinselele eziphathelene namajenerikhi ayinkimbinkimbi, kanye nokukhuthaza ukuncintisana kwamajenerikhi amaningi kule mithi, kuyingxenye ebalulekile yoHlelo Lwesenzo Sokuncintisana Kwezidakamizwa lwe-FDA, kanye nemizamo ye-ejensi yokukhuthaza ukufinyelela kwesiguli kanye nemithi ethengekayo.

I-FDA inikeze imvume yale budesonide ejwayelekile kanye ne-formoterol fumarate dihydrate inhalation aerosol ku-Mylan Pharmaceuticals, Inc.

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

Umhleli omkhulu we eTurboNews ezinze eTN HQ.

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