Alembic Pharma Gets USFDA Nod for Methotrexate Injection

New Delhi, Apr 16 (PTI) Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of methotrexate injection used in treatment of different types of cancers and arthritis.

The final approval granted by the the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Methotrexate injection of strengths 50 mg/2 ml multi-dose Vials and 1g/40 ml single-dose vials, Alembic Pharmaceuticals said in a statement.


The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), methotrexate injection 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials, of Hospira, Inc, it added.

Methotrexate Injection is indicated for neoplastic diseases, including acute lymphoblastic leukemia and meningeal leukemia.

It is also used in treatment of Osteosarcoma, breast cancer, squamous cell carcinoma of the head and neck, the company added. The injection is also indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe psoriasis, it added.