Treats newly-diagnosed low-risk acute promyelocytic leukemia (APL). ANDA 214011, held by Eugia Pharma. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 214011 (Arsenic Trioxide), held by Eugia Pharma, was first approved by FDA on Oct 15, 2021, with 1 approved supplement and 0 published complete response letters.
Arsenic trioxide injection is an arsenical indicated: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arsenic Trioxide2MG/ML · injectable;injection | Arsenic Trioxide | Discontinued |
| Jan 30, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 15, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
