Alembic Pharmaceuticals Secures USFDA Approval for Generic Cancer and Arthritis Injection
Alembic Pharma gets USFDA nod for generic cancer, arthritis injection
The Economic Times
Image: The Economic Times
Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic methotrexate injection, used to treat various cancers and arthritis. The approval covers both multi-dose and single-dose vials, making it therapeutically equivalent to the reference drug from Hospira, Inc.
- 01Alembic Pharmaceuticals has received USFDA approval for a generic methotrexate injection.
- 02The injection is used to treat several types of cancers and arthritis.
- 03Approval includes both 50 mg/2 ml multi-dose and 1g/40 ml single-dose vials.
- 04The generic version is therapeutically equivalent to Hospira's reference product.
- 05Methotrexate is indicated for conditions like acute lymphoblastic leukemia and rheumatoid arthritis.
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Alembic Pharmaceuticals Ltd, based in New Delhi, has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its generic version of methotrexate injection. This injection is crucial for treating various neoplastic diseases, including acute lymphoblastic leukemia, Osteosarcoma, and breast cancer, as well as conditions like rheumatoid arthritis and severe psoriasis. The approved generic methotrexate injection comes in two forms: 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials, and is considered therapeutically equivalent to the reference listed drug from Hospira, Inc. This approval is a significant milestone for Alembic Pharmaceuticals, enhancing its portfolio in the oncology and rheumatology sectors.
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This approval enables Alembic Pharmaceuticals to provide a more affordable option for patients requiring methotrexate, potentially improving access to essential cancer and arthritis treatments.
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