FDA — authorised 12 December 1995
- Application: NDA020599
- Marketing authorisation holder: AZURITY
- Local brand name: RILUTEK
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Rilutek in United States
FDA authorised Rilutek on 12 December 1995
Marketing authorisations
FDA — authorised 12 December 1995
- Marketing authorisation holder: COVIS PHARMA SARL
- Status: approved
FDA — authorised 29 January 2003
- Application: ANDA076173
- Marketing authorisation holder: IMPAX LABS
- Local brand name: RILUZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 2013
- Application: ANDA091417
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: RILUZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2016
- Application: ANDA204048
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: RILUZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2018
- Application: NDA209080
- Marketing authorisation holder: ITALFARMACO SA
- Local brand name: TIGLUTIK KIT
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 October 2018
- Application: ANDA204430
- Marketing authorisation holder: DAITO PHARMS CO LTD
- Local brand name: RILUZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 2019
- Application: ANDA206045
- Marketing authorisation holder: KENTON
- Local brand name: RILUZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 2022
- Application: ANDA091394
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA216035
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: RILUZOLE
- Indication: SUSPENSION — ORAL
- Status: approved
Rilutek 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 Rilutek approved in United States?
Yes. FDA authorised it on 12 December 1995; FDA authorised it on 12 December 1995; FDA authorised it on 29 January 2003.
Who is the marketing authorisation holder for Rilutek in United States?
AZURITY holds the US marketing authorisation.