FDA ta amince da ProAir HFA na farko

Labarai

Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba da izinin Perrigo da abokin aikinta na kamfanin Catalon Pharma Solutions don tsarin ProAir HFA na farko (albuterol sulfate). Inhaler mai ceto zai iya magance ko hana ƙwayar cuta ta hanji tare da cututtukan iska da za a iya hana su da motsa jiki da motsa jiki a cikin mutane masu shekaru 4 zuwa sama.

Teva, wanda ya ƙera ProAir, ya fitar da wani izini na kwayar ProAir a cikin Janairun 2019. Wannan sabon tsarin na AB da aka ƙididdige shi ne kwafin farko na asalin ƙirƙira, ba Teva ne ya samar da shi ba. Ya kamata ya fitar da farashi har ma da ƙasa. Watau, mutanen da ke fama da asma ba da daɗewa ba za su sami zaɓi mafi arha don taimaka musu numfashi cikin sauƙi.

ProAir shine mafi mashahurin inhaler mai ceto a Amurka Wannan jigilar albuterol sulfate inhalation aerosol samfurin yana ba da ƙarin zaɓi ga mutane miliyan 26 a Amurka waɗanda ke fama da asma, waɗanda da yawa daga cikinsu suna buƙatar amfani da duka magungunan sarrafawa na dogon lokaci da magani mai saurin aiki, kamar inhaler mai ceto.

Kamar ProAir HFA, nau'ikan sigar shine inhaler wanda za'a iya amfani dashi wanda mutane da asma zasu iya amfani dashi azaman magani mai sauri. Yana da nau'in magani wanda ake kira bronchodilator. Yana bayar da saurin-sauƙaƙewa ta hanyar shakatawa tsokoki a cikin hanyoyin iska, buɗe su don iska ta gudana. A cikin minutesan mintuna kaɗan na amfani da inhaler, maganin yana sauƙaƙa alamomin kamar shaƙar iska, matsewar kirji, da gajeren numfashi.

Yarda da wani Gena Proair HFA babbar nasara ce! in ji Shaili Gandhi, Pharm.D., Mataimakin shugaban aiyuka a SingleCare. Yana da wahala ga kamfanonin magani su sami izini don magunguna a cikin tsarin isar da hadaddun-wannan shine farkon inhaler da aka yarda da shi cikin shekaru 20.

A cewar kwamishinan FDA Stephen M. Hahn, MD, akwai dalilin jinkirin. Magungunan inshorar ƙaddara kamar waɗannan an san su da ƙwayoyin cuta masu rikitarwa, waɗanda a gargajiyance suke da wuyar kwafa saboda hadaddun tsarinsu ko yanayin isar da su, Hahn ya ce a cikin wata sanarwa da ke sanar da amincewar FDA a ranar 24 ga Fabrairu.

Magungunan zai ƙunshi inhalations metered 200. Adadin adadin zai iya bambanta, gwargwadon bukatun mai amfani. ( Bayanin tsarawa don ProAir HFA yana bada shawarar inha inha sau biyu a kowane awa hudu zuwa shida ko kuma inha biyu mintuna 15-30 kafin motsa jiki.) Kwararrun likitocin kiwon lafiya sun ba da shawarar cewa mutanen da suke bukatar yin amfani da inharshin ceto fiye da sau biyu a mako su tattauna halin da suke ciki da likitansu, domin suna iya bukatar daidaita su. magungunan sarrafawa na dogon lokaci.

Idan kana da asma kuma kayi amfani da inhaler mai ceto kamar ProAir HFA, wannan yardar na iya nufin ƙarin kuɗi a aljihunka. Dokta Gandhi ya ce, a shekarar da ta gabata, saida Proair HFA ya kai dala biliyan 1.4. Sanarwar gaba ɗaya zata taimaka rage nauyin kuɗi don yawancin masu amfani sun jimre. Za a iyakance sakin abin a farkon, amma kamfanin kera kayayyaki yana tsammanin samun wadatarwa a ƙarshen shekara.

Perrigo da takwaransa na Catalent sun tabbatar a cikin wata sanarwa da suka fitar a ranar 25 ga Fabrairu cewa suna shirin haɓaka haɓaka don saduwa da buƙatun da ake tsammani na gaba bayan ƙayyadadden wadataccen kasuwanci.Sauran nau'ikan nau'ikan nau'ikan nau'ikan nau'ikan inhaler na albuterol sun hada da Ventolin HFA , wanda kamfanin GlaxoSmithKline, da Proventil HFA suka kirkira, wanda kamfanin Merck Sharp & Dohme Corp ya kera shi.