I-generic Levothyroxine: Izinguquko eziphansi ezamukelekile

Izindinganiso eziphansi ezivunyiwe ze-Synthroid neLevoxyl

Ngo-June 23, 2004, i-US Food and Drug Administration (i-FDA) yase-United States inqatshelwe ukucela isikhalazo sokuthi u-Abbott - umenzi we-Synthroid - wafaka ngo-Agasti 2003 ngokuphathelene nama-bioequivalence we-levothyroxine imikhiqizo ye-sodium. Le nkampani ithi izindlela zokwenza i-bioequivalence zingaphansi kwephutha, futhi zingase zisho ukuthi imikhiqizo yobungako obuhlukile ingabhekwa njenge-bioequivalent.

Kodwa i-FDA, yavala lesi sicelo, esivule umnyango wemikhiqizo ejwayelekile ye-levothyroxine.

Abakhiqizi abaningi babelinde emaphikweni njengoba izinkampani ezintathu ezihlukene zazimemezela ngoJuni 24, 2004, ukuthi zamukele imvume ye-FDA yemikhiqizo yabo ejwayelekile ye-levothyroxine, kuhlanganise:

I-Mylan Laboratories - eyamukele imvume yamaphilisi e-sovothyroxine e-sodium ezinhlobonhlobo zamandla athandwayo, ama-generic versions we-Synthroid.

I-Sandoz Inc. - i-AB-ilinganiselwe (i-bioquivalent) levothyroxine kokubili Synthroid neLevoxyl.

I-Lannett Inkampani - kuvunyelwe i-levothyroxine eyenziwe nguJerome Stevens Pharmaceutical, Inc. (JSP), umhlinzeki okukhethekile we-Lannett, olingana neLevoxyl. Qaphela: Umkhiqizo okwenziwa nguJerome Stevens futhi usatshalaliswa nguLinnett, obuye wathengiswa ngaphansi kwegama elithi "Unithroid," kwakuyi-levothyroxine yokuqala evunywe yi-FDA.

Njengoba kungenzeka kulindeleke, abakhiqizi ababili begama le-brand levothyroxine ngaleso sikhathi, u-Abbott neNkosi, bahlose ukuvikela imikhiqizo yabo i-Synthroid neLevoxyl ngokulwa nokushaywa komncintiswano ophansi.



Lapho zonke izinkampani ezintathu ziqala ukuthumela izidakamizwa zabo ze-levothyroxine ngokushesha, bobabili u-Abbott neNkosi babona ukwehla kwamanani amasheya ngokulindela isabelo semakethe esilahlekile

Waba Namuphi Umphumela Ezigulini Zama-Thyroid?

Okokuqala, ibutho le-Abbott le-PR kanye nezidakamizwa zezidakamizwa lalingasebenzi, kuhlaziywa izintatheli nezintambo zokunyathelisa kanye nokuxhumana nama-pharmacy nodokotela ukuqhubeka nokuzama ukubeka iSythroid, isidakamizwa sesibili-esinqunyiwe e-United States, futhi umthombo wezigidi ezingu-818 wezigidi ekuthengiseni ngo-2003, njenge-levothyroxine "engcono".

Ngisho noma kungekho cwaningo lokusungula lokhu, futhi i-FDA ibike lezi zidakamizwa ezifanayo, kwakukhona i-pitch eqinile yokuthengisa ukuze ucindezele, ama-docs nama-pharmacy ku-Synthroid yonke futhi uhlukanise ama-generics. Lo mlayezo ubuye wachazwa odokotela, owatshela iziguli ukuthi "ama generic amasha awafani ne-Synthroid."

Okwesibili, izinkampani zezidakamizwa zamisa izimangalo ukuthi umkhiqizo owodwa wawungcono kunomunye noma ukuthi amabhizinisi angcono kunama-generics. Kuze kube manje, ukubuyekezwa kontanga, ukuphinda okuyimpumputhe kungazange kushicilelwe okuqhathanisa ukuphumelela kanye / noma ukuphakama kwemikhiqizo ethile ngokumelene nama generics, futhi abukho ubufakazi bokuthi uhlobo olulodwa lwe-levothyroxine lungcono kunolunye, noma ukuthi ama-generic enza ngokulinganayo kanye negama legama levothyroxine.

Okwesibili, izinkampani zomshuwalense nama-HMO zishintshe iziguli eziningi ngaphezu kwe-levothyroxine ejwayelekile. Kukhona abantu abaningi kakhulu kulezi zidakamizwa ukuthi ngisho namalandi ambalwa ama-dollar ngenyanga, uma kunwetshwa izinkulungwane zeziguli eziningi, kubangele ukugcinwa kwezindleko ezibalulekile lawo maqembu azofuna ukuwajabulela.