Application Nr Approved Date Route Status External Links
NDA208400 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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 ( 1.1 ). • Management Of Pediatric Patients With Active Polyarticular Juvenile Idiopathic Arthritis (Pjia) Who Are Intolerant Of Or Had An Inadequate Response To First-Line Therapy ( 1.2 ). 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. 1.2 Polyarticular Juvenile Idiopathic Arthritis Xatmep Is Indicated In The Management Of Pediatric Patients With Active Polyarticular Juvenile Idiopathic Arthritis (Pjia) Who Have Had An Insufficient Therapeutic Response To, Or Are Intolerant Of, An Adequate Trial Of First-Line Therapy Including Full Dose Non-Steroidal Anti-Inflammatory Agents (Nsaids).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methotrexate METHOTREXATE ZINC1529323

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