FDA — authorised 12 December 1995
- Application: NDA020599
- Marketing authorisation holder: AZURITY
- Local brand name: RILUTEK
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Riluzole (100 mg) in United States
FDA authorised Riluzole (100 mg) on 12 December 1995
Marketing authorisation
Riluzole (100 mg) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neurology approved in United States
Frequently asked questions
Is Riluzole (100 mg) approved in United States?
Yes. FDA authorised it on 12 December 1995.
Who is the marketing authorisation holder for Riluzole (100 mg) in United States?
AZURITY holds the US marketing authorisation.