Sabon Generic Symbicort na farko da FDA ta Amurka ta amince

A yau, Cibiyar Abinci da Magunguna ta Amurka ta amince da nau'in Symbicort na farko (budesonide da formoterol fumarate dihydrate) Inhalation Aerosol don kula da yanayin kiwon lafiya na huhu guda biyu: fuka a cikin marasa lafiya masu shekaru shida da haihuwa; da kuma kula da maganin hanawar iska da kuma rage rashin jin daɗi ga marasa lafiya da ke fama da cututtuka na huhu (COPD), ciki har da mashako na kullum da / ko emphysema. Wannan hadadden samfurin haɗe-haɗe na na'ura na ƙwayoyi, wanda shine ma'aunin inhales mai mitoci, bai kamata a yi amfani da shi ba don magance mummunan harin asma.

“Amincewar da aka yi a yau na farko na ɗaya daga cikin samfuran haɗaɗɗun magunguna da na’urorin da aka fi ba da izini don magance cutar asma da COPD wani mataki ne na gaba a cikin yunƙurinmu na kawo kwafin magunguna na yau da kullun zuwa kasuwa, waɗanda za su iya inganta rayuwa da kuma inganta rayuwar rayuwa. taimaka wajen rage farashin magani, "in ji Sally Choe, Ph.D., darektan Ofishin Magungunan Magunguna a Cibiyar Nazarin Magunguna da Magunguna ta FDA. "Wannan yana nuna ci gaba da ƙoƙarin FDA na haɓaka gasa da samun damar samun inganci, aminci, ingantattun magunguna masu araha ga marasa lafiya da masu siye."

Asthma na shafar mutane miliyan 25, fiye da miliyan biyar daga cikinsu yara ne, yayin da COPD ke fama da fiye da miliyan 16, a cewar Cibiyar Zuciya, Lung, da Cibiyar Jini. Ciwon asma cuta ce mai dadewa, mai dadewa wacce ke shafar hanyoyin iska a cikin huhu, wanda zai iya yin muni ta hanyar motsa jiki kuma galibi yana farawa lokacin ƙuruciya. Yana iya haifar da hushi (sautin husa lokacin numfashi), ƙarancin numfashi, da tari. COPD, wanda ya haɗa da emphysema da mashako na yau da kullum, ciwo ne na dogon lokaci, cututtuka na yau da kullum wanda ke haifar da toshewar iska kuma yana da wuyar numfashi.

Wannan samfurin haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe ne (MDI), wanda ya ƙunshi duka budesonide (corticosteroid wanda ke rage kumburi) da kuma formoterol (wani mai aiki na dogon lokaci wanda ke kwantar da tsokoki a cikin hanyoyin iska don haɓaka numfashi). Numfashi biyu, sau biyu a rana (yawanci safe da dare, kusan awanni 12 tsakanin juna), suna magance cututtukan guda biyu ta hanyar hana bayyanar cututtuka, irin su hushi ga masu ciwon asma, da kuma taimakawa wajen samun ingantacciyar numfashi, ga masu COPD. An yarda da inhaler don ƙarfi biyu (160/4.5 mcg/actuation da 80/4.5 mcg/actuation).

Mafi yawan abubuwan da ke tattare da budesonide da formoterol fumarate dihydrate na numfashi na baki aerosol ga masu fama da asma sune nasopharyngitis (kumburi na hanci da baya na makogwaro), ciwon kai, kamuwa da cututtuka na numfashi na sama, pharyngoloryngeal (hanci da baki) zafi, sinusitis, mura. , ciwon baya, cunkoson hanci, rashin jin dadin ciki, amai, da candidiasis na baka (thrush). Ga wadanda ke da COPD, illolin da aka fi sani sune nasopharyngitis, candidiasis na baka, mashako, sinusitis, da kuma kamuwa da kwayar cutar ta sama.

FDA a kai a kai yana ɗaukar matakai don taimakawa masana'antu jagora ta hanyar haɓakawa don samfuran magunguna iri ɗaya, gami da samfuran haɗin gwiwa, kamar MDI, waɗanda suka ƙunshi magani da na'ura. Don ƙara sauƙaƙe haɓakar haɓakar ƙwayoyi, da kuma taimakawa masana'antar harhada magunguna gabaɗaya a cikin wannan tsari, FDA ta buga takamaiman jagorar samfuri (PSGs) da ke kwatanta tunani da tsammanin hukumar a halin yanzu kan yadda za a haɓaka samfuran magunguna waɗanda ke daidai da sunan alamarsu. takwarorinsu. A cikin Yuni 2015, FDA ta buga PSG don budesonide da formoterol fumarate dihydrate inhalation aerosol.

FDA na buƙatar masu tallafawa su ƙaddamar da bayanai masu dacewa da bayanai don nuna cewa hadaddun samfuran haɗin magunguna da na'urorin sun cika ƙaƙƙarfan ƙa'idodin amincewar hukumar. Waɗannan ƙa'idodin suna tabbatar da cewa samfuran magunguna na gabaɗaya suna da aminci da tasiri kamar daidaitattun sunansu kuma sun cika ma'auni masu inganci iri ɗaya.

Haɗaɗɗen samfura samfuran likita ne inda rashin tabbas game da hanyar amincewa ko yuwuwar hanyoyin haɓaka samfur za su iya amfana daga sa hannu na kimiyya na farko, kamar samfura tare da hadaddun kayan aiki masu ƙarfi da samfuran haɗin na'urar magani. Tunda samfuran hada-hadar miyagun ƙwayoyi na iya zama mafi ƙalubale don haɓakawa, ƙarancin wanzuwa, yana haifar da ƙarancin gasar kasuwa. Magance matsalolin da suka shafi rikice-rikicen ilimin halittar, da kuma inganta ƙarin gasar da shirin kwarin gwiwa na FDA, kuma kokarin inganta magunguna masu haƙuri.

FDA ta ba da izinin wannan jeri-ka-ficen budesonide da formoterol fumarate dihydrate inhalation aerosol zuwa Mylan Pharmaceuticals, Inc.