Mumbai, April 16 -- The approved product includes 50 mg/2 mL (25 mg/mL) multi-dose vials and 1 g/40 mL (25 mg/mL) single-dose vials. The drug is a folate analog metabolic inhibitor used in the treatment of various neoplastic diseases, including acute lymphoblastic leukemia, meningeal leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, and head and neck squamous cell carcinoma. It is also indicated for rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis.

The approved ANDA is therapeutically equivalent to the reference listed drug, Methotrexate Injection USP, manufactured by Hospira Inc.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 236 ANDA approvals from the USFDA, including 218...