FDA — authorised 6 May 2024
- Application: ANDA218354
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: EDARAVONE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 TW001 in United States
FDA authorised TW001 on 6 May 2024
Marketing authorisations
FDA — authorised 6 May 2024
- Application: ANDA216199
- Marketing authorisation holder: GLAND
- Local brand name: EDARAVONE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 October 2024
- Application: ANDA217565
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: EDARAVONE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 December 2024
- Application: ANDA216902
- Marketing authorisation holder: SANDOZ
- Local brand name: EDARAVONE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA218349
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: EDARAVONE
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is TW001 approved in United States?
Yes. FDA authorised it on 6 May 2024; FDA authorised it on 6 May 2024; FDA authorised it on 31 October 2024.
Who is the marketing authorisation holder for TW001 in United States?
LONG GROVE PHARMS holds the US marketing authorisation.