FDA final approval confirms therapeutic equivalence to Hospira’s methotrexate injection USP at identical strengths and vial presentations, enabling market entry via the abbreviated generic pathway.
Methotrexate injection is indicated for certain cancers as well as for the treatment of rheumatoid arthritis and other ailments.
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 the treatment of different types of ...
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