Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration for its generic version of Methotrexate injection, used in the treatment of various cancers and arthritis.

The approval pertains to the company’s abbreviated new drug application (ANDA) for Methotrexate injection in strengths of 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials.

Alembic stated that the approved product is therapeutically equivalent to the reference listed drug (RLD), Methotrexate injection, marketed by Hospira Inc.