Teva announced that the FDA has approved preservative-free Methotrexate injection, USP. Methotrexate, an antimetabolite, is a folic acid antagonist used to treat certain types of cancer including cancers that begin in the tissues that form around a fertilized egg in the uterus, breast cancer, lung cancer, certain cancers of the head and neck, certain types of lymphoma, and leukemia (cancer that begins in the white blood cells). It is also used to treat severe psoriasis and active rheumatoid arthritis (RA).

In response to the methotrexate shortage in February, the FDA expedited application reviews of preservative-free formulations and engaged many firms to assist in maintaining supplies to meet patient needs.

Methotrexate injection from Teva is expected to be available in July 2012. It will be supplied as a 25mg/mL concentration solution in 2mL-, 4mL-, 10mL-, and 40mL glass vials.

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