Nuwamba 2023: Under Project Renewal, an Oncology Centre of Excellence (OCE) initiative aimed at updating labelling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date, the Food and Drug Administration (FDA) approved updated labelling for temozolomide (Temodar, Merck). Under this experimental programme, this is the second medication to have its label updated. Capecitabine (Xeloda) was the first medication approved under Project Renewal.
Ta hanyar yunƙurin haɗin gwiwa na Sabuntawar Aikin, masana kimiyyar farko-farko da ƙwararrun ilimin likitanci na waje suna nazarin wallafe-wallafen da aka buga don samun gogewa ta hanun kan zaɓi, sarrafawa, da kimanta bayanai don bitar FDA mai zaman kanta. Manufar Sabuntawar Aikin shine a kula da mafi yawan lakabin kwanan nan don tsofaffi, magungunan cututtukan daji da aka tsara akai-akai yayin da ake ƙara ilimin jama'a game da lakabin miyagun ƙwayoyi azaman tushen bayanai da bayar da buɗaɗɗen buƙatun shaida na FDA da tsarin tantancewa.
Yanzu an amince da Temozolomide don sabbin abubuwan da aka sake dubawa:
- Adjuvant magani na manya tare da sabon bincike anaplastic astrocytoma.
- lura da manya tare da refractory anaplastic astrocytoma.
One approved indication for temozolomide remains the same:
- treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.
Ƙarin sake fasalin alamar sun haɗa da:
- An sake bita da sabunta tsarin sayan don sabon bincike na glioblastoma da astrocytoma na anaplastic.
- Don Temodar capsules, ana ƙara bayani kan haɗari daga fallasa zuwa buɗaɗɗen capsules a ƙarƙashin Gargadi da Kariya.
- Sashen Bayanin Shawarar Mara lafiya da Takaddun Bayanin Mara lafiya an sabunta su kuma an sake duba su.
