FDA inobvumira Gilenya generic
NhauKweanoda kusvika makore gumi, vanhu vane kesi dzinodzokororazve dze multiple sclerosis (MS) vaive neimwe nzira yekurapa. Gilenya . Yaive yega mishonga inogamuchirwa neDFA kune vanhu vakuru uye vana vane makore gumi zvichikwira, kusvika svondo rapfuura.
Musi waZvita 5, iyo U.S. Chikafu uye Dhiraimendi Administration (FDA) yakaziviswa kubvumidzwa kwegeneral Gilenya, fingolimod, kune HEC Pharm Co Limited, Biocon Limited, uye Sun Pharmaceutical Industries Limited.
Chii chinonzi Gilenya?
Yakagadzirwa naNovartis Pharmaceuticals Corporation, Gilenya yakatanga kubvumidzwa neFDA mugore ra2010. Yaive yekutanga kurapwa kwemuromo yakagadzirirwa kudzikisira kudzokedzana uye kunonoka kufambira mberi kwechirwere. In 2018 , iyo FDA yakawedzera kubvumidzwa kwayo kwemushonga kusanganisira varwere vevana.
Iyo parizvino yakakurudzirwa dosi yeGilenya yevakuru nevana vane makore gumi kana kupfuura uye vanorema makumi mana emakirogiramu imwe chete 0.5 mg capsule pazuva. Vana vane makore angangoita gumi asi vachirema makumi mana emakirogiramu kana zvichidzika vanofanirwa kutora imwe 0.25 mg kapisi pazuva.
Chii chinonzi MS?
MS chirwere chekuzvidzivirira chega, zvinoreva kuti masero emumuviri anodzivirira kufukidza kwemafuta etsinga, kukanganisa mafungidziro etsinga uye kukonzera zviratidzo senge kushomeka kwemhasuru, kuneta, kupera simba kana kurira. kusagadzikana. Vanhu vazhinji vanoona kutenderera kwekutangazve kunoteverwa nekuregererwa. Nekufamba kwenguva, zvinonetsa kuzadzikisa kuregererwa kwakazara mushure mekuputika, uye chirwere ichi chichienderera mberi.
Gilenya ndiwo mushonga unonyanya kushandiswa muzviitiko izvi. Iyo inofungidzirwa kuti inoshanda nekudzora maseru ekudzivirira anotenderera mumuviri, nokudaro achideredza kurwiswa kwemaseru etsinga anokonzera zviratidzo.
Marii yakawanda sei Gilenya?
Pamwe nekuda kwekudzivirirwa kwepatent, mutengo weGilenya wakaramba wakakwira-mutengo wepakati we $ 8,211 yekutengeswa kwemazuva makumi matatu e 0.5mg capsules.Kunyange, Novartis inotaura kuti mazhinji einishuwarenzi ehutano anovhara mishonga, kusanganisira 99% yevanhu vane inishuwarenzi yekutengesa uye 96% yevanhu vane Medicaid kana Medicare. Novartis inopawo maviri co-kubhadhara mapurogiramu ekutsigira kubhadharira mushonga.
Uku kubvumidzwa inhanho yekutanga kuenda kumakwikwi ejenareta, ayo anogona kudzikisira mitengo yekurapa uku.
Kugadzirisa matambudziko ane chekuita nekugadzira majeniki uye kusimudzira kwakawanda generic chikamu chakakosha cheDDA's Drug Kukwikwidza Chiitiko Chirongwa uye kuedza kwesangano kubatsira kuwedzera mukana wevarwere kumishonga inodhura, iyo FDA chirevo akadaro.
Generic Gilenya ichawanikwa riini?
Izvo hazvisati zvaziviswa kuti vagadziri vatatu vemishonga vakagamuchira mvumo vachatanga kutengesa iyo fingolimod (Gilenya generic) muUnited States. Hapana chimiro chemutengo chiripo, zvimwe.
