FDA imavomereza generic yoyamba ProAir HFA
NkhaniUS Food and Drug Administration (FDA) idapatsa Perrigo ndi mnzake Catalent Pharma Solutions chilolezo choyambirira cha ProAir HFA generic (albuterol sulfate). The inhaler yopulumutsa imatha kuchiza kapena kupewa bronchospasm ndimatenda obwezeretsa m'mlengalenga komanso bronchospasm yochita zolimbitsa thupi mwa anthu azaka 4 kapena kupitilira apo.
Teva, wopanga ProAir, adatulutsa ProAir yovomerezeka mu Januware 2019. Mtundu watsopanowu wa AB-mtundu woyamba ndiye mtundu woyamba wa zopangidwa zoyambirira, osati zopangidwa ndi Teva. Iyenera kuyendetsa mitengo ngakhale yotsika. Mwanjira ina, anthu omwe ali ndi mphumu posachedwa adzakhala ndi njira yotsika mtengo yowathandizira kupuma mosavuta.
ProAir ndiwopulumutsa kwambiri wotchuka ku US Izi generic albuterol sulphate Kutulutsa mpweya wabwino kumawonjezeranso mwayi kwa anthu 26 miliyoni ku United States omwe ali ndi mphumu, ambiri mwa iwo amafunika kugwiritsa ntchito mankhwala osokoneza bongo kwa nthawi yayitali komanso mankhwala achangu, ngati opulumutsa inhaler.
Monga ProAir HFA, mtundu wa generic ndi muyeso wa inhaler womwe ungagwiritsidwe ntchito ndi anthu omwe ali ndi mphumu ngati mankhwala achangu. Ndi mtundu wa mankhwala wotchedwa bronchodilator. Amapereka mpumulo mwachangu mwa kupumula minofu munjira zoyendetsera ndege, kuwatsegulira mpweya kuti udutse. Pakangopita mphindi zochepa chabe mutagwiritsa ntchito inhaler, mankhwalawa amachepetsa zizindikilo monga kupuma, kufinya pachifuwa, komanso kupuma movutikira.
Kuvomerezeka kwa Proair HFA generic ndichinthu chofunikira kwambiri! akuti Shaili Gandhi, Pharm.D., Wachiwiri kwa purezidenti wazoyambitsa ku SingleCare. Ndizovuta kuti makampani azamankhwala avomerezedwe ndimankhwala osokoneza bongo munjira zoperekera zovuta-iyi ndiye njira yoyamba yopumira yomwe imavomerezedwa zaka 20.
Malinga ndi Commissioner wa FDA a Stephen M. Hahn, MD, pali chifukwa chochedwetsera. Ma inhalers a metered ngati awa amadziwika kuti ma generic ovuta, omwe mwamwambo amakhala ovuta kutengera chifukwa cha kapangidwe kake kovuta kapena njira yoberekera, Hahn adati m'mawu ake akulengeza kuvomerezedwa kwa FDA pa Feb. 24.
Mankhwalawa amakhala ndi inhalation 200 mita. Kuchuluka kwa mlingo kumatha kusiyanasiyana, kutengera zosowa za wogwiritsa ntchito. ( Kupereka chidziwitso cha ProAir HFA amalimbikitsa kupumira kawiri maola anayi kapena asanu ndi limodzi kapena kupuma kawiri mphindi 15-30 musanachite masewera olimbitsa thupi.) Akatswiri azaumoyo amati anthu omwe amafunikira kugwiritsa ntchito kupulumutsa mankhwalawa kawiri pamlungu amakambirana zaumoyo wawo ndi adotolo, chifukwa angafunike kusintha mankhwala a nthawi yayitali.
Ngati muli ndi mphumu ndikugwiritsa ntchito pulogalamu yopulumutsa monga ProAir HFA, kuvomereza kumeneku kumatha kutanthauza ndalama zambiri m'thumba lanu. Chaka chatha, malonda a Proair HFA anali pafupifupi $ 1.4 biliyoni, akutero Dr. Gandhi. Kutulutsidwa kwa generic kumathandizira kuchepetsa mtengo womwe owerenga ambiri amapirira. Kutulutsidwa kwa generic kudzakhala kochepa poyamba, koma kampani yopanga zida ikuyembekeza kuti izikhala yolimba kumapeto kwa chaka.
Perrigo ndi mnzake Catalent adatsimikiza m'mawu omwe adatulutsidwa pa Feb. 25 kuti akukonzekera kupititsa patsogolo zokolola kuti akwaniritse zomwe akuyembekezeredwa mtsogolo pambuyo pogulitsa koyamba kochepa.Mayina amtundu wina wa albuterol inhaler ndi awa Ventolin HFA , yomwe imapangidwa ndi GlaxoSmithKline, ndi Proventil HFA, yopangidwa ndi Merck Sharp & Dohme Corp.
