Mavesi Otsika Ovomerezeka a Synthroid ndi Levoxyl
Pa June 23, 2004, US Food and Drug Administration (FDA) inatsutsa Citizen Petition yomwe Abbott - maker wa Synthroid - adaitumiza mu August 2003 ponena za bioequivalence ya mankhwala a sovothyroxine. Kampaniyo inati njira zogwiritsira ntchito bioequivalence zinali zolakwika, ndipo zikhoza kutanthawuza kuti malonda awo a zizindikiro zosiyana angatengedwe mofanana.
Koma a FDA adatsutsa pempholi, lomwe latsegula chitseko cha mankhwala a levothyroxine.
Ambiri opanga makinawa anali kuyembekezera m'mapiko ngati makampani atatu omwe adalengezedwa pa June 24, 2004, kuti adalandira chivomerezo cha FDA chifukwa cha mankhwala awo a levothyroxine, kuphatikizapo:
Mylan Laboratories - yomwe inalandira chivomerezo kwa mapiritsi a sovothyroxine sodium m'zinthu zosiyanasiyana zotchuka, Synthroid.
Sandoz Inc. - AB-rated (bioequivalent) levothyroxine kwa Synthroid ndi Levoxyl.
Company Lannett - kuvomerezedwa ndi levothyroxine yopangidwa ndi Jerome Stevens Pharmaceutical, Inc. (JSP), katundu wa Lannett yekha, omwe ali ofanana ndi Levoxyl. Zindikirani: Zopangidwa ndi Jerome Stevens ndi kugawidwa ndi Lannett, yomwe imagulitsidwanso pansi pa dzina lakuti "Unithroid," inali levothyroxine yoyamba yomwe inavomerezedwa ndi FDA.
Malinga ndi zomwe tingayembekezere, azimayi awiri otchedwa levothyroxine opanga panthawiyo, Abbott ndi King, adathamanga kuti ateteze mankhwala awo Synthroid ndi Levoxyl polimbana ndi chiwonetsero chatsopano cha mpikisano wotsika mtengo.
Makampani atatuwa atayamba kutumiza mankhwala awo a levothyroxine nthawi yomweyo, onse awiri Abbott ndi King adapeza madontho amtengo wogulitsa pofuna kuyembekezera kuwonetsedwa kwa msika
Kodi Zotsatirapo za Odwala Chithokomiro Zinakhudza Bwanji?
Choyamba, asilikali a Abbott a PR ndi mankhwala osokoneza bongo anali atagwira ntchito, kuvulaza atolankhani ndi atolankhani ndi madokotala ndi madokotala kuti apitirize kuyesa kuika Synthroid, mankhwala achiwiri kwambiri ku United States, ndipo gwero la $ 818 miliyoni mu malonda mu 2003, monga levothyroxine "bwino".
Ngakhale kuti panalibe kafukufuku kuti atsimikizire izi, ndipo FDA adalengeza mankhwalawa, adalonda kwambiri, amalonda ndi ma pharmine ku Synthroid onse ndipo amatsutsana ndi zowonjezera. Uthenga uwu, womwewo, unalinso wofotokozedwa ndi madokotala, omwe anawauza odwala kuti "zowonjezera zatsopano sizofanana ndi Synthroid."
Chachiwiri, makampani osokoneza bongo anaimitsa zonena kuti mtundu wina unali wabwino kuposa wina kapena kuti mankhwalawa ndi abwino kusiyana ndi ma generics. Pakadali pano, kafukufuku wamakono, wofufufumitsa sanapangidwenso woyerekeza kuti akufaniziranso mphamvu ndi / kapena zamtengo wapatali pamagulu osiyana siyana, ndipo palibe umboni wakuti levothyroxine imodzi ndi yabwino kuposa ina, kapena kuti Mankhwalawa samagwira ntchito mofananamo komanso mankhwala otchedwa levothyroxine mankhwala.
Chachitatu, makampani a inshuwalansi ndi ma HMO adasintha odwala ambiri kupita ku levothyroxine ya generic. Pali anthu ochuluka kwambiri pa mankhwalawa omwe ngakhale ndalama zochepa pamwezi, omwe amachulukitsidwa ndi odwala zikwi zambiri, zimapangitsa ndalama zambiri kuti maguluwa azikhala osangalala.