I-generic Levothyroxine: Iingqinisiso eziphantsi kweendleko ezivunyiweyo

Iingqinisiso eziphantsi kweendleko ze-Synthroid neLevoxyl

NgoJuni 23, 2004, i-US Food and Drug Administration (i-FDA) yaphikisana neSicelo soPhando seCitizen sokuthi u-Abbott - umenzi we-Synthroid - wayefake ngo-Agasti 2003 ngokumalunga ne-bioequivalence ye-levothyroxine. Le nkampani yathi iindlela zokwazisa i-bioequivalence zingaphantsi kwephutha, kwaye zinokuba zithetha ukuba iimveliso zendlela ezahlukileyo ziya kuthathwa njenge-bioequivalent.

Kodwa-ke, i-FDA, yavala le sicelo, evule umnyango wemveliso ye-levothyroxine.

Abakhiqizi abaninzi babelinde ngamaphiko njengeenkampani ezintathu ezahlukileyo ezazishunyayelwa ngoJuni 24, 2004, ukuba zifumene imvume ye-FDA kwimveliso yabo ye-levothyroxine, kuquka:

I-Mylan Laboratories - eyayifumana imvume yeephilisi ze-levothyroxine ze-sodium kwiintlobo ezininzi zamandla amaninzi, ii-generic versions ze-Synthroid.

I-Sandoz Inc. - I-AB-ilinganiswe (i-bioequivalent) levothyroxine kokubili i-Synthroid neLevoxyl.

I-Lannett Inkampani - ukuvunywa kwe-levothyroxine eyenziwe nguJerome Stevens Pharmaceutical, Inc. (JSP), umthengisi ngokukhethekileyo kaLinnett, olingana neLevoxyl. Qaphela: Imveliso eyenziwe nguJerome Stevens kwaye isasazwa nguLinnett, esithengiswa phantsi kwegama elithi "Unithroid," yayiyi-levothyroxine yokuqala evunywe yi-FDA.

Njengoko kunokulindelwa, abenzi begama elingu-top levothyroxine ngelo xesha, u-Abbott noKumkani, bafuna ukukhusela imveliso yabo i-Synthroid kunye neLevoxyl malunga nokuhlaselwa okutsha komncintiswano ophantsi.



Xa zonke iinkampani ezintathu zaqala ukuthumela izidakamizwa zabo ze-levothyroxine ngokukhawuleza, bobabini uAbbott noKumkani babona amaconsi kwixabiso lesitokethi ngokulindeleka kwe-market share lost

Yaba yintoni Impembelelo kwizigulane ze -roid?

Okokuqala, umkhosi wase-Abbott we-PR kunye nezixhobo zeziyobisi wawungasebenzi, ukuhlaziya iincwadi zenkampani zenkampani kunye neenkcukacha zogcino kunye noogqirha kunye noogqirha ukuba baqhubeke bezama ukubeka iSystroid, isicatshulwa sesibini-e-United States, kunye nemithombo eyi-818 yezigidi ekuthengiseni ngo-2003, njenge-levothyroxine "engcono".

Nangona bekungekho uphando lokuseka oku, kwaye i-FDA yayibhengeze leziyobisi ezifanayo, kwakukho i-pitch eqingqiweyo yokuthengisa ukucoca, ii-docs kunye nee-pharmacy kwi-Synthroid kunye nokudibanisa i-generics. Lo myalezo, wabuye wavakaliswa oogqirha, owatsho izigulane ukuba "ii-generics ezintsha azifani ne-Synthroid."

Okwesibini, iinkampani zonyango ziye zalisa amabango ukuba enye ibhanki ibhetele kunomnye okanye ukuba iimveliso zibhetele kunezobugcisa. Okwangoku, ukuphononongwa koontanga, uphando oluphinda kabini lungakhange lushicilelwe olufanisa ukuphumelela kunye / okanye ukuphakama kweempawu ezithile ngokuchasene ne-generics, kwaye akukho bukho ubungqina bokuba olunye uhlobo lwe-levothyroxine lungcono kunomnye, okanye ukuba i-generics ayenzi ngokulinganayo kunye negama legama levothyroxine.

Okwesithathu, iinkampani ze-inshorensi kunye nee-HMO zatshintsha izigulane ezininzi ukuya kwi-levothyroxine yexabiso eliphantsi. Kukho abantu abaninzi kangaka kulezi zonyango ezithi zidibanise ezimbalwa ngeenyanga, zisongezwa ngamawaka amaninzi ezigulane, zibangele ukugcinwa kweendleko ezibonakalayo ezi maqela azakufuna ukuzinandipha.