Symbicort yoyamba yatsopano yovomerezeka ndi US FDA

A GWIRITSANI KwaulereKutulutsidwa 5 | eTurboNews | | eTN
Avatar ya Linda Hohnholz
Written by Linda Hohnholz

Masiku ano, US Food and Drug Administration inavomereza generic yoyamba ya Symbicort (budesonide ndi formoterol fumarate dihydrate) Inhalation Aerosol pofuna kuchiza matenda awiri a m'mapapo: mphumu kwa odwala azaka zisanu ndi chimodzi kapena kuposerapo; ndi kukonzanso chithandizo cha kutsekeka kwa mpweya ndi kuchepetsa kuwonjezereka kwa odwala omwe ali ndi matenda aakulu a m'mapapo a m'mapapo (COPD), kuphatikizapo matenda a bronchitis ndi / kapena emphysema. Chida chophatikizika chamankhwala chovuta ichi, chomwe ndi inhaler ya metered-dose, sayenera kugwiritsidwa ntchito pochiza chifuwa cha mphumu.

"Lero kuvomereza kwa generic yoyamba ya mankhwala omwe amapangidwa kuti athetse chifuwa chachikulu cha mphumu ndi COPD ndi sitepe inanso pakudzipereka kwathu kubweretsa makope a generic a mankhwala ovuta pamsika, omwe amatha kusintha moyo wawo komanso kuthandiza kuchepetsa mtengo wa chithandizo,” anatero Sally Choe, Ph.D., mkulu wa Office of Generic Drugs mu FDA Center for Drug Evaluation and Research. "Izi zikuwonetsa kuyesetsa kwa FDA kukulitsa mpikisano komanso mwayi wopeza mankhwala abwino, otetezeka, ogwira ntchito komanso otsika mtengo kwa odwala ndi ogula."

Matenda a mphumu amakhudza anthu 25 miliyoni, oposa mamiliyoni asanu omwe ali ana, pamene COPD imakhudza anthu oposa 16 miliyoni, malinga ndi National Heart, Lung, and Blood Institute. Chifuwa ndi matenda osatha, okhalitsa omwe amakhudza njira ya mpweya m'mapapo, yomwe imatha kuipiraipira chifukwa chochita masewera olimbitsa thupi ndipo nthawi zambiri imayamba ali mwana. Kukhoza kuyambitsa kupuma (phokoso la mluzu popuma), kupuma movutikira, ndi kutsokomola. COPD, yomwe imaphatikizapo emphysema ndi bronchitis yosatha, ndi matenda a nthawi yayitali, omwe amachititsa kuti mpweya usatseke ndipo zimapangitsa kuti zikhale zovuta kupuma.

Chida chophatikizira chamankhwala ichi ndi metered-dose inhaler (MDI), yomwe ili ndi budesonide (corticosteroid yomwe imachepetsa kutupa) ndi formoterol (bronchodilator yomwe imagwira ntchito nthawi yayitali yomwe imatsitsimutsa minofu munjira za mpweya kuti ipume bwino). Kupuma kawiri pa tsiku (kawirikawiri m'mawa ndi usiku, pafupifupi maola 12 motalikirana), kuchitira matenda onsewa popewa zizindikiro, monga kupuma kwa omwe ali ndi mphumu, komanso pothandizira kupuma bwino, kwa omwe ali ndi COPD. Inhaler imavomerezedwa kuti ikhale ndi mphamvu ziwiri (160/4.5 mcg/actuation ndi 80/4.5 mcg/actuation).

Zotsatira zoyipa kwambiri zomwe zimagwirizanitsidwa ndi budesonide ndi formoterol fumarate dihydrate oral inhalation aerosol kwa omwe ali ndi mphumu ndi nasopharyngitis (kutupa kwa mphuno ndi kumbuyo kwa mmero), mutu, matenda am'mwamba, pharyngolaryngeal (mphuno ndi pakamwa) ululu, sinusitis, fuluwenza. , kupweteka kwa msana, kutsekeka kwa mphuno, kupweteka m'mimba, kusanza, ndi candidiasis m'kamwa (thrush). Kwa iwo omwe ali ndi COPD, zotsatira zofala kwambiri ndi nasopharyngitis, oral candidiasis, bronchitis, sinusitis, ndi matenda a m'mwamba.

A FDA nthawi zonse amatengapo kanthu kuti athandizire kutsogolera makampani popanga zinthu zopangidwa ndi generic, kuphatikiza zophatikiza, monga ma MDIs, zomwe zimakhala ndi mankhwala ndi zida. Pofuna kupititsa patsogolo chitukuko cha mankhwala a generic, ndikuthandizira makampani opanga mankhwala a generic kuti achite izi, a FDA amasindikiza malangizo okhudzana ndi mankhwala (PSGs) kufotokoza maganizo a bungweli ndi zomwe akuyembekezera pa momwe angapangire mankhwala a generic omwe ali ofanana ndi dzina lawo. anzawo. Mu June 2015, FDA idatulutsa PSG ya budesonide ndi formoterol fumarate dihydrate inhalation aerosol.

A FDA amafuna othandizira kuti apereke deta yoyenera ndi chidziwitso kuti awonetsere kuti mankhwala ophatikizika amtundu wamtundu uliwonse amakwaniritsa miyezo yovomerezeka ya bungweli. Miyezo iyi imawonetsetsa kuti mankhwala amtundu uliwonse amakhala otetezeka komanso ogwira mtima monga momwe amafananira ndi dzina lawo ndipo amakwaniritsa miyezo yapamwamba kwambiri.

Zogulitsa zovuta ndi zamankhwala pomwe kusatsimikizika kokhudza njira yovomerezeka kapena njira zina zopangira zinthu zitha kupindula ndi zomwe asayansi adakumana nazo koyambirira, monga zinthu zomwe zimakhala ndi zosakaniza zovuta komanso zophatikiza ndi zida zamankhwala. Popeza kuti mankhwala ophatikizana ndi mankhwala amatha kukhala ovuta kupanga, ochepa amakhalapo, zomwe zimapangitsa kuti msika ukhale wocheperako. Kuthana ndi zovuta zokhudzana ndi ma generic ovuta, komanso kulimbikitsa mpikisano wambiri wamankhwala pamankhwalawa, ndi gawo lofunikira la FDA's Drug Competition Action Plan, komanso zoyesayesa za bungwe lolimbikitsa kupezeka kwa odwala komanso mankhwala otsika mtengo.

A FDA adavomereza za budesonide ndi formoterol fumarate dihydrate inhalation aerosol ku Mylan Pharmaceuticals, Inc.

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Avatar ya Linda Hohnholz

Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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