Treats acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy…. NDA 208400, held by Azurity. Methotrexate Sodium.
As of Nov 13, 2026, NDA 208400 (Xatmep), held by Azurity, was first approved by FDA on Apr 25, 2017, with 2 approved supplements and 0 published complete response letters.
XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen. Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy. 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.
| Apr 25, 2017 | Original applicationNew dosage form · Standard review | Approved | |
| Apr 25, 2017 | Original applicationEfficacy (new indication or use) · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XatmepEQ 2.5MG BASE/ML · solution;oral | Methotrexate Sodium | RxReference drug |
| May 27, 2026 | Supplement 5Labeling · Standard review | Approved | |
| Mar 15, 2018 | Supplement 2Labeling | Approved | |
| Apr 25, 2017 | Original applicationNew dosage form · Standard review | Approved | |
| Apr 25, 2017 | Original applicationEfficacy (new indication or use) · Standard review | Approved |
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
