Alembic Pharmaceuticals Limited announced on April 16, 2026, that it secured final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Methotrexate Injection USP.The approved product addresses two formulations: Multi-Dose Vials of 50 mg/2 mL (25 mg/mL) and Single-Dose Vials of 1g/40 mL (25 mg/mL). This approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Methotrexate Injection USP, manufactured by Hospira, Inc.Methotrexate Injection is a folate analog metabolic inhibitor used in the treatment and prophylaxis of several conditions. Its indicated uses include neoplastic diseases, such as Acute Lymphoblastic Leukemia, Meningeal Leukemia...