Tolvaptan
Tolvaptan, kaadol antuk wastan merek Samsca pantaraning sane lianan, inggih punika tamba akuaretik sane mafungsi dados antagonis reseptor vasopresin 2 (V 2 ) sane selektif, kompetitif sane kaanggen nambanin hiponatremia (kadar natrium darah sane rendah) sane mapaiketan sareng gagal jantung kongestif, sirosis antiuretik saking SIDH, lan sindrosis sinpropriat saking SIDH). Tolvaptan sampun kacumpuin olih Badan Pengawas Obat dan Makanan AS (FDA) duk tanggal 19 Mei 2009, taler kaadol olih Otsuka Pharmaceutical Co antuk wastan dagang Samsca. [1] Tolvaptan, pinaka Jynarque, polih persetujuan kaanggen ring medis ring Amerika Serikat ring bulan April 2018. [2]
Badan Pengawas Obat dan Makanan AS (FDA) ngicen tolvaptan sebutan jalur gelis anggen uji klinis sane nyelehin kawigunannyane anggen nambanin pinungkan ginjal polikistik . [3] FDA ngicenin Jynarque sebutan tamba yatim piatu duk April 2012, anggen nambanin pinungkan ginjal polikistik dominan autosom. [4]
Tolvaptan wenten pinaka tamba generik. [5] [6]
- ↑ "Drug Approval Package: Samsca (Tolvaptan) Tablets NDA #022275". U.S. Food and Drug Administration (FDA). 21 July 2009. Kaaksés 15 August 2020.
- ↑ "Drug Approval Package: Jynarque (tolvaptan)". U.S. Food and Drug Administration (FDA). 8 June 2018. Kaaksés 15 August 2020.
- ↑ "Otsuka Maryland Research Institute, Inc. Granted Fast Track Designation For Tolvaptan In PKD". Medical News Today. Healthline Media UK Ltd. Kaaksés 6 December 2018.
- ↑ "Tolvaptan Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 6 April 2012. Kaaksés 15 August 2020.
- ↑ "Drugs@FDA: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Kaaksés 15 August 2020.
- ↑ "Tolvaptan Accord: Pending EC decision". European Medicines Agency (EMA). 26 January 2023. Kaarsipin saking versi asli tanggal 27 January 2023. Kaaksés 28 January 2023.