FDA — authorised 31 August 2018
- Application: ANDA208231
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ATO in United States
FDA authorised ATO on 31 August 2018 · 75 US adverse-event reports
Marketing authorisations
FDA — authorised 13 November 2018
- Application: ANDA206228
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 November 2018
- Application: ANDA210802
- Marketing authorisation holder: AMRING PHARMS
- 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 15 November 2018
- Application: ANDA209315
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 2019
- Application: ANDA209873
- Marketing authorisation holder: PENN LIFE
- 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 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
FDA
- Application: ANDA078729
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ARSENIC TRIOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 21 April 2025 – 21 April 2026
- Total reports: 75
Most-reported reactions
- Acute Promyelocytic Leukaemia Differentiation Syndrome — 16 reports (21.33%)
- Electrocardiogram Qt Prolonged — 13 reports (17.33%)
- Leukaemia Recurrent — 8 reports (10.67%)
- Myelodysplastic Syndrome Transformation — 8 reports (10.67%)
- Leukopenia — 7 reports (9.33%)
- Infection — 6 reports (8%)
- Pyrexia — 5 reports (6.67%)
- Acute Promyelocytic Leukaemia — 4 reports (5.33%)
- Haematotoxicity — 4 reports (5.33%)
- Haemorrhage — 4 reports (5.33%)
ATO 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 ATO 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 ATO in United States?
FRESENIUS KABI USA holds the US marketing authorisation.