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Stride Arcolab Arm Gets US FDA Nod For Methotrexate Injection

Strides Arcolab Ltd. said its wholly-owned subsidiary Onco Therapies Ltd., obtained US FDA approvals for Methotrexate Injection USP 25mg/ mL packaged in 1 gm/40 m, 50mg/2 mL, 100mg/ 4mL, 200mg/8 mL and 250mg/10 mL single dose vials - preservative-free.

Methotrexate is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market. The company said it would launch the product shortly.

Methotrexate 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.

Methotrexate is amongst the products in the drug shortage list of US FDA, the company said.

As per IMS data, the US market for generic Methotrexate is around $13 million.

At the BSE, Stride Arcolab closed Friday's trading at Rs.580, down 1.62 percent from the previous close.

by RTTNews Staff Writer

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