FDA approves methotrexate oral solution Xatmep for JIA, lymphoblastic leukemia
The FDA has approved Xatmep, an oral methotrexate solution for the treatment of polyarticular juvenile idiopathic arthritis in children with inadequate response to NSAIDs and for children with acute lymphoblastic leukemia as part of multiphase combination chemotherapy.
“Xatmep is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tables or compounding into a liquid formulation,” Frank Segrave, president and chief executive officer of Silvergate Pharmaceuticals, said in a company release.
Xatmep is recommended as a 2.5-mg per mL formulation, which requires refrigeration, but can be stored at room temperature for 60 days after dispensing.
“As a company, we continue to focus on pediatric medications that are safe, effective and readily available,” Segrave said.