Leli Philisi Lokulawula Ukuzalwa Liyakhunjulwa Ngenxa Yamaphutha Okupakisha

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Namuhla emaphusheni amabi okuphila, amaphilisi okulawula inzalo enkampani eyodwa ayakhunjulwa ngoba kunengozi enkulu yokuthi abawenzi umsebenzi wabo. I-FDA imemezele ukuthi i-Apotex Corp ikhumbula amanye amaphilisi ayo e-drospirenone ne-ethinyl estradiol ngenxa yamaphutha okupakisha. (Okuhlobene: Nansi Indlela Yokuthola Ukulawulwa Kokubeletha Kulethwe Khona Emnyango Wakho)

"Amaphutha okupakisha" abhekise ekutheni ahlelwe kanjani amaphilisi: Njengoba kwenzeka kaningi, amaphilisi enkampani eza ngamaphakethe ezinsuku ezingama-28, namaphilisi angama-21 aqukethe ama-hormone namaphilisi ayisikhombisa angenawo. Amaphakethe we-Apotex ngokuvamile aqukethe amaphilisi asebenzayo aphuzi amasonto amathathu aneviki elilodwa lama-placebos amhlophe. Inkinga ukuthi, amanye amaphakethe kubikwa ukuthi anohlelo olungalungile lwamaphilisi aphuzi namhlophe, noma anamaphakethe angenalo nhlobo iphilisi.

Njengoba ukuthatha amaphilisi okulawula ukubeletha ngaphandle kokuhleleka noma ukweqa usuku olusebenzayo kukhulisa kakhulu amathuba akho okukhulelwa, i-Apotex ikhumbula amaqoqo afaka phakathi amaphakethe angasebenzi kahle. (Okuhlobene: Ingabe Kuphephile Ukweqa Isikhathi Sakho Ngenhloso Ngenkathi Uthatha Ukulawulwa Kokuzalwa?)

Uma lokhu kukhumbula kukhala insimbi, lokho kungenxa yokuthi i-FDA yenze izimemezelo ezimbili ezifanayo kwinkumbulo yakamuva: U-Allergan wenza isikhumbuzo sokulawulwa kokuzalwa ngo-2018 ku-Taytulla, njengoba kwenza u-Janssen ku-Ortho-Novum. Njengakhumbula manje i-Apotex Corp., womabili ahlobene nokupakisha okungalungile kwamaphilisi kunokuzibandakanya namaphilisi uqobo. Ngasohlangothini oluhle, i-FDA ayizange ibike noma yikuphi ukukhulelwa okungafuneki noma imiphumela emibi exhunywe kunoma yikuphi kokukhunjulwa abathathu. (Okuhlobene: I-FDA Isanda Kugunyaza Uhlelo Lokusebenza Lokuqala Ukumakethwa Ukulawula Ukuzalwa)

Ngokwesitatimende se-FDA, ukukhumbula kuka-Apotex Corp kudlulela ezinkambisweni ezine zokulawulwa kokuzalwa kwenkampani. Ukuze uthole ukuthi isilawuli sakho sokuzalwa sifakiwe yini, hlola iphakheji. Uma ubona inombolo ye-NDC 60505-4183-3 kwikhathoni engaphandle noma ku-60505-4183-1 kwikhathoni elingaphakathi, kuyingxenye yesikhumbuzo, kodwa uma unemibuzo, ungashayela i-Apotex Corp. ngo-1-800- 706-5575. Uma unephakethe elithintekile, i-FDA incoma ukuthi uxhumane nomhlinzeki wakho wezokunakekelwa kwezempilo ukuze uthole iseluleko futhi ushintshele kwifomu lokulawula ukubeletha elingelona elejwayelekile.

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