Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited, has announced that it has received two US FDA abbreviated new drug application (ANDA) approvals for fluorouracil injection USP.
The injections are 50 mg / mL, packaged in 10 mL and 20 mL single-dose vials, besides pharmacy bulk packages of 2.5 g/ 50 mL and 5 g / 100 ml.
Fluorouracil is amongst the products in the drug shortage list of US FDA. According to IMS data, the US market for generic fluorouracil is approximately US$ 14 million. It is part of the Oncology portfolio licensed to Pfizer for the US market and expected to be launched shortly.
Fluorouracil belongs to the class of chemotherapy drugs known as anti-metabolites. It interferes with cells making DNA and RNA, which stops the growth of cancer cells and is used to treat several types of cancer including colon, rectum, and head and neck cancers.