FDA — authorised 14 November 2008
- Marketing authorisation holder: EISAI INC
- Status: approved
🇺🇸 Banzel in United States
FDA authorised Banzel on 14 November 2008
Marketing authorisations
FDA — authorised 14 November 2008
- Application: NDA021911
- Marketing authorisation holder: EISAI INC
- Local brand name: BANZEL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2016
- Application: ANDA205075
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: RUFINAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2016
- Application: ANDA204988
- Marketing authorisation holder: HIKMA
- Local brand name: RUFINAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2016
- Application: ANDA205095
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: RUFINAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2019
- Application: ANDA211388
- Marketing authorisation holder: BIONPHARMA
- Local brand name: RUFINAMIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 April 2019
- Application: ANDA207363
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 23 February 2021
- Application: ANDA213410
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: RUFINAMIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 August 2022
- Application: ANDA204964
- Marketing authorisation holder: LUPIN
- Local brand name: RUFINAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2022
- Application: ANDA216549
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RUFINAMIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 7 November 2022
- Application: ANDA214009
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RUFINAMIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 May 2023
- Application: ANDA216688
- Marketing authorisation holder: MICRO LABS
- Local brand name: RUFINAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2023
- Application: ANDA217230
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 5 December 2023
- Application: ANDA216841
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: RUFINAMIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA214817
- Marketing authorisation holder: MSN
- Local brand name: RUFINAMIDE
- Indication: SUSPENSION — ORAL
- Status: approved
Banzel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Banzel approved in United States?
Yes. FDA authorised it on 14 November 2008; FDA authorised it on 14 November 2008; FDA authorised it on 16 May 2016.
Who is the marketing authorisation holder for Banzel in United States?
EISAI INC holds the US marketing authorisation.