FDA — authorised 31 August 2018
- Application: ANDA208231
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Trisenox in United States
FDA authorised Trisenox on 31 August 2018
Marketing authorisations
FDA — authorised 13 November 2018
- Application: ANDA210802
- Marketing authorisation holder: AMRING PHARMS
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 November 2018
- Application: ANDA206228
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Trisenox for labeling indication on July 8, 2024. The marketing authorization holder is ZYDUS PHARMS. The approval was granted under the standard expedited pathway.
FDA — authorised 15 November 2018
- Application: ANDA209315
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 2018
- Application: ANDA209780
- Marketing authorisation holder: NEXUS
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 2021
- Application: ANDA210739
- Marketing authorisation holder: AMNEAL
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 October 2021
- Application: ANDA215059
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 15 October 2021
- Application: ANDA214011
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 December 2021
- Application: ANDA215359
- Marketing authorisation holder: SANDOZ
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 April 2023
- Application: ANDA217413
- Marketing authorisation holder: MSN
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Trisenox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Trisenox approved in United States?
Yes. FDA authorised it on 31 August 2018; FDA authorised it on 13 November 2018; FDA authorised it on 13 November 2018.
Who is the marketing authorisation holder for Trisenox in United States?
FRESENIUS KABI USA holds the US marketing authorisation.