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  • SUSPENSION;ORAL - 40MG/ML
  • TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 400MG

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217230

FDA
16 Jun 2023

https://www.eisai.com/news/2022/news202275.html

EISAI
02 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216549

FDA
26 Oct 2022

https://www.expresspharma.in/lupin-receives-us-fda-approval-for-rufinamide-tablets/

EXPRESS PHARMA
18 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204964

FDA
17 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213457

FDA
29 Dec 2020

http://www.pharmabiz.com/NewsDetails.aspx?aid=134302&sid=2

PHARMABIZ
22 Dec 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211388

FDA
25 Apr 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207363

FDA
25 Apr 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207363

FDA
15 Jan 2019

https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia

TGA
09 Jul 2018

https://www.pharmacompass.com/pdf/news/banzelrufinamide-eisai-co-v-bionpharma-1525071719.pdf

PATENT LITIGATION
24 Apr 2018

https://www.pharmacompass.com/pdf/news/roxanes-generic-rufinamide-approved-in-us-as-an-anticonvulsant-medication-1463569742.pdf

FDA
16 May 2016

https://www.pharmacompass.com/pdf/news/glenmarks-generic-rufinamide-approved-in-us-as-an-anticonvulsant-medication-1463569696.pdf

FDA
16 May 2016

https://www.pharmacompass.com/pdf/news/mylan-pharms-generic-rufinamide-approved-in-us-as-an-anticonvulsant-medication-1463569637.pdf

FDA
16 May 2016

http://www.prnewswire.com/news-releases/presentados-nuevos-datos-de-practica-clinica-sobre-el-uso-de-zebinix-acetato-de-eslicarbazepina-para-tratar-las-crisis-de-inicio-parcial-en-la-reunion-anual-de-la-sociedad-americana-de-epilepsia-aes-561277221.html

PR NEWS WIRE
09 Dec 2015

http://www.prnewswire.com/news-releases/zebinix-acetate-deslicarbazepine-dans-la-prise-en-charge-des-crises-partielles-depilepsie-nouvelles-analyses-de-donnees-de-vie-reelle-presentees-lors-du-congres-annuel-de-lamerican-epilepsy-society-aes-560733251.html

PR NEWS WIRE
07 Dec 2015

http://www.prnewswire.com/news-releases/los-resultados-finales-del-estudio-epos-presentados-en-el-congreso-internacional-de-epilepsia-iec-muestran-que-el-tratamiento-adyuvante-con-zebinix-acetato-de-eslicarbazepina-mejora-la-calidad-de-vida-525801711.html

PR NEWS WIRE
08 Sep 2015

http://eisai.mediaroom.com/2015-04-30-Eisai-and-Glenmark-Reach-Settlement-over-Generic-Version-of-BANZEL-rufinamide

Press Release EISAI
30 Apr 2015

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/01/report-card-fda-gets-a-solid-b-on-timely-responding-to-section-505w-discontinuation-citizen-petition.html

Kurt R. Karst FDA LAW BLOG
25 Jan 2015
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