I-FDA ivuma iProAir HFA yokuqala ejwayelekile
IzindabaUkuphathwa Kwezokudla Nezidakamizwa e-U.S. I-FDA kunikeze uPerrigo kanye nozakwethu uCatalent Pharma Solutions ukugunyazwa kweProAir HFA generic yokuqala (albuterol sulfate) yokuqala. I-inhaler yokutakula ingaphatha noma ivimbele i-bronchospasm ngesifo esivimbela ukugeleza kwomoya esivimbelayo kanye ne-bronchospasm ebangelwa ukuvivinya umzimba kubantu abaneminyaka engu-4 nangaphezulu.
UTeva, umkhiqizi weProAir, ukhiphe uhlobo olujwayelekile olugunyaziwe lweProAir ngoJanuwari 2019. Le nguqulo entsha ekalwe i-AB yikhophi yokuqala yokwakheka kwasekuqaleni, ayikhiqizwa yiTeva. Kufanele kushayele amanani entengo ngisho aphansi. Ngamanye amagama, abantu abane-asthma kungekudala bazoba nenketho eshibhile yokubasiza baphefumule kalula.
ProAir yi-inhaler yokutakula ethandwa kakhulu e-U.S. Le generic i-albuterol sulfate Umkhiqizo we-aerosol we-inhalation unikeza okunye ukukhetha kubantu abayizigidi ezingama-26 e-United States abanesifuba somoya, iningi labo okudingeka basebenzise kokubili umuthi wokulawula isikhathi eside nomuthi osebenza ngokushesha, njenge-inhaler yokutakula.
NjengeProAir HFA, inguqulo ejwayelekile iyi-metered dose inhaler engasetshenziswa ngabantu abane-asthma njengomuthi osebenza ngokushesha. Luhlobo lomuthi obizwa nge-bronchodilator. Inikeza ukukhululeka okusheshayo ngokuxegisa imisipha ezindleleni zomoya, ivulekele umoya ogelezayo. Emaminithini ambalwa nje wokusebenzisa i-inhaler, umuthi unciphisa izimpawu ezinjengokuvunguza, ukuqina kwesifuba, nokuphefumula okuncane.
Ukuvunywa kwe-Proair HFA ejwayelekile kuyimpumelelo enkulu! Kusho uShaili Gandhi, uPharm.D., usekela mongameli wezinto ezenziwa e-SingleCare. Kunzima ezinkampanini zemithi ukuthi zithole ukuvunywa kwezidakamizwa ezinhlelweni zokulethwa eziyinkimbinkimbi — lesi yisithako sokuqala se-generic mether inhaler esivunyelwe eminyakeni engama-20.
Ngokusho kukaKhomishani we-FDA uStephen M. Hahn, MD, kunesizathu sokubambezeleka. Ama-inhalers ama-metered dose afana nalawa aziwa njenge-generic eyinkimbinkimbi, ngokwesiko okunzima ukuyikopisha ngenxa yokwakheka kwayo okuyinkimbinkimbi noma indlela yokulethwa kwayo, kusho uHahn esitatimendeni esimemezela ukuvunywa kwe-FDA ngoFebhuwari 24.
Umuthi uzoqukatha ukuhogela okungamamitha ayi-200. Inani lesilinganiso lingahluka, ngokuya ngezidingo zomsebenzisi. ( Imininingwane ebekwayo yeProAir HFA uncoma ukuhogela umoya kabili phakathi kwamahora amane kuya kwayisithupha noma ukuhogela kabili emizuzwini engu-15 kuya kwengama-30 ngaphambi kokuzivocavoca. imithi yokulawula isikhathi eside.
Uma une-asthma futhi usebenzisa i-inhaler yokutakula efana ne-ProAir HFA, lokhu kuvunywa kungasho imali eningi ephaketheni lakho. Ngonyaka odlule, ukuthengiswa kweProair HFA cishe kwakungu- $ 1.4 billion, kusho uDkt Gandhi. Ukukhishwa okujwayelekile kuzosiza ukunciphisa umthwalo wezindleko abasebenzisi abaningi ababekezelayo. Ukukhishwa kwe-generic kuzoba nomkhawulo ekuqaleni, kepha inkampani ekhiqizayo ilindele ukutholakala okuzinzile ngasekupheleni konyaka.
UPerrigo nozakwabo uCatalent baqinisekise esitatimendeni esikhishwe ngoFebhuwari 25 ukuthi bahlela ukukhulisa umkhiqizo ukuze bahlangabezane nezidingo ezilindelekile zesikhathi esizayo ngemuva kokutholakala kokuhweba okulinganiselwe kokuqala.Ezinye izinhlobo zamagama alolu hlobo ze-albuterol inhaler zifaka I-Ventolin HFA , eyenziwe yiGlaxoSmithKline, neProventil HFA, eyenziwa ngabakwaMerck Sharp & Dohme Corp.
