Strides Arcolab arm gets USFDA approval for anti-cancer drug

Onco Therapies, a wholly owned subsidiary of pharma major Strides Arcolab, has received approval from the US Food and Drug Administration (US FDA) to market its cancer drug, 'Methotrexate Injection', in the US.

'Methotrexate Injection' is the generic equivalent of 'Fluorouracil Injection USP', part of the oncology portfolio licensed to Pfizer for the US market and expected to be launched shortly, the company said in a press statement.

Methotrexate (Fluorouracil) is a chemotherapy drug, which interferes with cells making DNA and RNA, and stops the growth of cancer cells. It is used to treat several types of cancer, including colon, rectum, and head and neck cancers.

Fluorouracil is at present in USFDA's list of products that are in short supply, the company said, adding that the US market for generic Fluorouracil is approximately $14 million, according to IMS data.

Methotrexate is used either alone or in combination with other agents for chemotherapy. It is also used to treat some autoimmune diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus and Crohn's disease.