Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi-Dose Vials & 1g/40 mL (25 mg/mL) Single Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi- Dose Vials & 1g/40 mL (25 mg/mL) Single Dose Vials, of Hospira, Inc. Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases: i) Acute Lymphoblastic Leukemia, ii) Meningeal Leukemia: Prophylaxis and Treatment, iii) Non-Hodgkin Lymphoma, iv) Osteosarcoma, v) Breast Cancer, vi) Squamous Cell Carcinoma of the Head and Neck, and vii) Gestational Trophoblastic Neoplasia. It is also indicated for the treatment of: i) rheumatoid arthritis (RA), ii) polyarticular juvenile idiopathic arthritis (pJIA), and iii) severe psoriasis. |