Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab, has received US FDA approvals for methotrexate injection USP 25 mg/ mL packaged in 1 gram/ 40 m, 50 mg/2 mL, 100 mg / 4 mL, 200 mg/ 8 mL and 250 mg / 10 mL single dose vials (preservative-free)

Methotrexate is amongst the products in the drug shortage list of US FDA.  According to IMS data, the US market for generic methotrexate is approximately USD 13 million.

Methotrexate is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. It  is a chemotherapy drug used either alone or in combination with other agents.  It is used as a treatment for some autoimmune diseases including: rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus and Crohn's disease, to name a few.