Chekutanga generic nyowani Symbicort yakatenderwa neUS FDA

Nhasi, US Food and Drug Administration yakabvumira yekutanga generic yeSymbicort (budesonide uye formoterol fumarate dihydrate) Inhalation Aerosol yekurapa maitiro maviri ehutano hwemapapu: asthma muvarwere vane makore matanhatu uye kupfuura; uye kuchengetedza kurapwa kwekuvharidzirwa kwemhepo uye kuderedza kuwedzera kwevarwere vane chirwere chisingaperi chemapapu (COPD), kusanganisira chisingaperi bronchitis uye / kana emphysema. Ichi chakaomarara generic drug-device musanganiswa chigadzirwa, inova metered-dose inhaler, haifanirwe kushandiswa kurapa acute asthma kurwiswa.

"Nhasi kubvumidzwa kwekutanga generic kune imwe yeanowanzo kunyorerwa yakaoma zvinodhaka-musanganiswa zvigadzirwa kurapa asima neCOPD nderimwe danho remberi mukuzvipira kwedu kuunza makopi egeneric emishonga yakaoma kumusika, inogona kuvandudza hupenyu uye. kubatsira kuderedza mutengo wekurapa,” akadaro Sally Choe, Ph.D., mutungamiriri weHofisi yeGeneric Drugs muFDA Center for Drug Evaluation and Research. "Izvi zvinoratidza kuenderera mberi kweFDA kuedza kuwedzera makwikwi uye kuwana mishonga yemhando, yakachengeteka, inoshanda uye inokwanisika kuvarwere nevatengi."

Asthma inobata vanhu mamirioni makumi maviri nemashanu, vanopfuura mamirioni mashanu vari vana, nepo COPD ichitambudza vanopfuura mamirioni gumi nematanhatu, sekureva kweNational Heart, Lung, uye Blood Institute. Asthma chirwere chisingaperi, chenguva refu chinokanganisa nzira dzemhepo mumapapu, izvo zvinogona kuipisisa nekuita zvemuviri uye kazhinji zvinotanga panguva yehudiki. Inogona kukonzera kuhwihwidza (kuridza muridzo paunenge uchifema), kutadza kufema, uye kukosora. COPD, iyo inosanganisira emphysema uye chronic bronchitis, chirwere chenguva refu, chisingaperi chinokonzera kuvharika kwemhepo uye chinoita kuti zviome kufema.

Ichi chigadzirwa chemushonga-musanganiswa wemishonga ndeye metered-dose inhaler (MDI), iyo ine zvose budesonide (corticosteroid inoderedza kuzvimba) uye formoterol (bronchodilator inogara kwenguva refu inozorodza tsandanyama mumhepo kuti ivandudze kufema). Kufemba kaviri, kaviri pazuva (kazhinji mangwanani neusiku, anenge maawa gumi nemaviri zvakaparadzana), bata hosha mbiri idzi nekudzivirira zviratidzo, sekufema kune avo vane asima, uye nekubatsira nekufema kuri nani, kune avo vane COPD. Iyo inhaler inotenderwa kune maviri masimba (12/160 mcg/actuation uye 4.5/80 mcg/actuation).

Migumisiro yakajairika ine chekuita nebudesonide uye formoterol fumarate dihydrate oral inhalation aerosol kune avo vane asthma ndeye nasopharyngitis (kuzvimba kwemhino nekuseri kwehuro), kutemwa nemusoro, hutachiona hwepamusoro hwekufema, pharyngolaryngeal (mhino nemuromo) kurwadziwa, sinusitis, furuwenza. , kurwadziwa kwemusana, kuvhara kwemhino, kusagadzikana kwemudumbu, kurutsa, uye candidiasis yemuromo (thrush). Kune avo vane COPD, mhedzisiro inowanzoitika ndeye nasopharyngitis, oral candidiasis, bronchitis, sinusitis, uye hutachiona hwepamusoro hwekufema.

Iyo FDA inogara ichitora matanho ekubatsira kutungamira indasitiri kuburikidza nekuvandudza maitiro ezvigadzirwa zvemishonga, zvinosanganisira zvigadzirwa zvakasanganiswa, zvakaita seMDIs, zvinosanganisira mushonga nemudziyo. Kuenderera mberi kufambisa kugadzirwa kwemishonga yegeneric, uye kubatsira indasitiri yemishonga yegeneric mukuita uku, FDA inoburitsa zvigadzirwa-zvakananga nhungamiro (PSGs) inotsanangura mafungiro uye zvinotarisirwa nesangano iri panzira yekugadzira zvigadzirwa zvemishonga zvegeneric izvo zvinoenderana nerapo zita rechiratidzo. vamwe. Muna Chikumi 2015, FDA yakaburitsa PSG yebudesonide uye formoterol fumarate dihydrate inhalation aerosol.

Iyo FDA inoda vatsigiri kuti vaunze data rakakodzera uye ruzivo kuratidza kuti yakaoma generic drug-device musanganiswa zvigadzirwa zvinosangana neyakaomarara yekubvumidza mwero. Aya mazinga anovimbisa kuti zvigadzirwa zvegeneric zvinodhaka zvakachengeteka uye zvinoshanda semazita emhando yemhando uye zvinosangana zvakafanana zvemhando yepamusoro.

Zvigadzirwa zvakaomarara zvigadzirwa zvekurapa uko kusava nechokwadi nezve nzira yemvumo kana dzimwe nzira dzinobvira dzekuvandudza chigadzirwa dzinogona kubatsirwa kubva mukuita kwesainzi kwekutanga, senge zvigadzirwa zvine zvakaoma zvinosanganisa zvinosanganisa uye zvigadzirwa zvemusanganiswa wezvinodhaka. Sezvo zvigadzirwa zvemusanganiswa wezvinodhaka zvichigona kunetsa kugadzira, zvishoma zviripo, zvichikonzera kukwikwidza kushoma kwemusika. Kugadzirisa matambudziko ane chekuita nemishonga yakaoma, uye kusimudzira makwikwi egeneric kumishonga iyi, chikamu chakakosha cheFDA's Drug Competition Action Plan, uye kuedza kwesangano kusimudzira kuwanikwa kwevarwere uye nemishonga inodhura.

Iyo FDA yakapa mvumo yeiyi generic budesonide uye formoterol fumarate dihydrate inhalation aerosol kuMylan Pharmaceuticals, Inc.