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Strides Arcolab receives USFDA approval for Fluorouracil injection

19 Jul 2012 Evaluate

Strides Arcolab (Strides) has received 2 ANDA approvals from USFDA for Fluorouracil Injection USP, 50 mg/ ml, packaged in 10 ml and 20ml single- dose vials, 2.5 g / 50 ml and 5 g/100 ml pharmacy bulk packages.

Fluorouracil is amongst the product in the drugs shortage list of USFDA. According to IMS data the US market for generic fluorouracil is approximately USD 14 million. Fluorouracil is part of the oncology portfolio licensed to Pfizer for US market and expected to be launched shortly.

Fluorouracil belongs to the class of chemotherapy drugs known as anti - metabolites it interferes with the cells making DNA and RNA, which stops the growth of cancer cells and is used to treat several type of caner including colon, rectum and head and neck cancers

Strides Arcolab is a global pharmaceuticals headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceuticals products with an emphasis on sterile injectables.

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