I-FDA ivuma iProAir HFA yokuqala yohlobo

Iindaba

Ulawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) lunike iPerrigo kunye neqabane layo iCatalent Pharma Solutions ukuba ivume iProAir HFA generic (albuterol sulfate) yokuqala. I-inhaler yokuhlangula inokunyanga okanye ithintele i-bronchospasm ngesifo esibuyela umva esibuhlungu kunye nokusebenzisa umthambo kubantu abakwiminyaka eyi-4 nangaphezulu.

UTeva, umvelisi weProAir, ukhuphe i-generic egunyazisiweyo yeProAir ngoJanuwari 2019. Olu hlobo lutsha lwenqanaba le-AB yikopi yokuqala yoqulunqo lwantlandlolo, olungaveliswanga yiTeva. Kuya kufuneka iqhube amaxabiso asezantsi. Ngamanye amagama, abantu abane-asthma kungekudala baya kuba neendlela ezingabizi kakhulu zokubanceda baphefumle ngokulula.

IproAir yeyona inhaler ixhaphakileyo yohlangulo eMelika Le generic albuterol sulphate Imveliso ye-inhalation ye-aerosol inika ukhetho olongezelelekileyo kubantu abazizigidi ezingama-26 e-United States abanesifuba, uninzi lwabo oludinga ukusebenzisa amayeza olawulo lwexesha elide kunye neyeza elisebenza ngokukhawuleza, njenge-inhaler yokuhlangula.

NjengeProAir HFA, inguqulelo yohlobo oluqhelekileyo yithamo le-metered inhaler elinokusetyenziswa ngabantu abane-asthma njengeyeza elisebenza ngokukhawuleza. Luhlobo lonyango olubizwa ngokuba yi-bronchodilator. Inika isiqabu esikhawulezileyo ngokuphumla kwezihlunu kwiindlela zomoya, zivulekele umoya ukuze ungene. Kwimizuzu nje embalwa usebenzisa i-inhaler, iyeza linciphisa iimpawu ezinje ngokuvutha, ukuqina kwesifuba kunye nokuphefumla okufutshane.

Ukuphunyezwa kweProjeric generic HFA yimpumelelo ebalulekileyo! Utshilo uShaili Gandhi, uFhd.D., usekela-mongameli weenkqubo ezisesikweni kwi-SingleCare. Kunzima kwiinkampani zamachiza ukuba zifumane imvume kumachiza kwiinkqubo ezintsonkothileyo zokuhambisa- le yeyokuqala ithamo le-generic ye-inhaler evunyiweyo kwiminyaka engama-20.

Ngokomkomishinala we-FDA uStephen M. Hahn, MD, kukho isizathu sokulibaziseka. I-inhalers yedosi emiselweyo efana nale yaziwa njenge-genics ezintsonkothileyo, ngokwesiko ekunzima ukuzikopa ngenxa yendlela ezintsonkothileyo okanye indlela yokuhanjiswa, utshilo uHahn kwingxelo ebhengeza ukuvunywa kwe-FDA ngoFebruwari 24.

Iyeza liza kuba ne-inhalations ezingama-200 zeemitha. Imali yesilinganiselo ingahluka, ngokuxhomekeke kwiimfuno zomsebenzisi. ( Ingcaciso emiselweyo yeProAir HFA icebisa ukuphefumla kabini qho emva kweeyure ezine ukuya kwezintandathu okanye inhalation ezimbini imizuzu engama-15 ukuya kwengama-30 ngaphambi kokuba wenze umthambo. amayeza olawulo lwexesha elide.

Ukuba une-asthma kwaye usebenzisa i-inhaler yokuhlangula njengeProAir HFA, le mvume inokuthetha imali eninzi epokothweni. Kunyaka ophelileyo, intengiso yeProair HFA yayimalunga ne-1.4 yezigidigidi zeedola, utshilo uGqirha Gandhi. Ukukhutshwa okuqhelekileyo kuya kunceda ukunciphisa umthwalo weendleko abaninzi abasebenzisi abanyamezelayo. Ukukhutshwa kwe-generic kuya kuncitshiswa ekuqaleni, kodwa inkampani evelisa izinto ilindele ukubonelelwa okuzinzileyo ekupheleni konyaka.

UPerrigo kunye neqabane lakhe uCatalent baqinisekisile kwingxelo ekhutshwe ngoFebruwari 25 ukuba baceba ukonyusa imveliso ukuhlangabezana nebango elilindelweyo elizayo emva konikezelo lokuqala olunqongopheleyo lworhwebo.Olunye uhlobo lwegama lophawu lolu hlobo lwealbuterol inhaler lubandakanya IVentolin HFA Yenziwe nguGlaxoSmithKline, kunye neProventil HFA, eyenziwe nguMerck Sharp kunye noDohme Corp.