Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi-Dose Vials and 1g/40 mL (25 mg/mL) Single Dose Vials.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi- Dose Vials and 1g/40 mL (25 mg/mL) SingleDose Vials, of Hospira, Inc.

Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases like Acute Lymphoblastic Leukemia, Meningeal Leukemia: Prophylaxis and Treatment, Non-Hodgkin Lymphoma, Osteosarcoma, Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, and Gestational Trophoblastic Neoplasia.

It is also indicated for the treatment of Rheumatoid Arthritis (RA); polyarticular Juvenile Idiopathic Arthritis (pJIA), and severe psoriasis.

Alembic has a cumulative total of 236 ANDA approvals (218 final approvals and 18 tentative approvals) from FDA.