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Alembic Pharma wins USFDA nod for generic methotrexate injection for cancer and arthritis
Business
Published on 24 April 2026

Approval confirms therapeutic equivalence to a key Hospira drug
Alembic Pharmaceuticals has received USFDA final approval for its generic methotrexate injection, a widely used medicine for multiple cancers and inflammatory conditions. The regulator greenlit key dosage formats and confirmed therapeutic equivalence to the reference Hospira product, clearing the way for Alembic to market the injectable in the US for cancers and conditions like rheumatoid arthritis and severe psoriasis.
- USFDA grants final approval to Alembic’s generic methotrexate injection
- Therapeutic equivalence confirmed versus Hospira reference product
- Approval covers multiple dosage formats for broader launch readiness
- Methotrexate treats cancers and inflammatory diseases including RA and psoriasis
Read the full story at The Economic Times
This summarization was done by Beige for a story published on
The Economic Times
