Treats T-cell acute lymphoblastic leukemia (T-ALL) and … lymphoblastic lymphoma (T-LBL). ANDA 216346, held by Amneal. Nelarabine.
As of Nov 14, 2026, ANDA 216346 (Nelarabine), held by Amneal, was first approved by FDA on Apr 4, 2023, with 1 approved supplement and 0 published complete response letters.
Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 4, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nelarabine250MG/50ML (5MG/ML) · injectable;intravenous | Nelarabine | Rx |
| Nov 6, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 4, 2023 | 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
