Treats T-cell acute lymphoblastic leukemia (T-ALL) and … lymphoblastic lymphoma (T-LBL). ANDA 216038, held by Meitheal. Nelarabine.
As of Nov 14, 2026, ANDA 216038 (Nelarabine), held by Meitheal, was first approved by FDA on Jan 10, 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 Injection 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 |
|---|---|---|---|
| Jan 10, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nelarabine250MG/50ML (5MG/ML) · injectable;intravenous | Nelarabine | Rx |
| Sep 1, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 10, 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
