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Indian drug firm Strides Arcolab today announced it had received approval from the USFDA for the its generic Fluorouracil Injection which will be used to treat various types of cancer. The company's wholly-owned subsidiary Onco Therapies Ltd has received two approvals from the United States Food and Drug Administration for its abbreviated new drug applications (ANDA) for Fluorouracil Injection USP in two strengths, Strides Arcolab said in a statement.
The approvals are for the injection in the strengths of 50 mg / ml, packaged in 10 ml and 20 ml single-dose vials and 2.5 g/ 50 ml and 5 g / 100 ml pharmacy bulk packages, it added. Fluorouracil is among the products in the drug shortage list of USFDA and according to IMS data, the US market for generic Fluorouracil is nearly $14 million, it said.
"It is part of the oncology portfolio licensed to Pfizer for the US market and expected to be launched shortly," it added. Fluorouracil is used to treat several types of cancers including that of colon, rectum, and head and neck.
This is not the first instance of an Indian company launching a generic drug in the US market. Indian pharma Lupin received FDA approval for a generic version of LYRICA which will be used to treat nerve pain. Earlier Dr Reddy's launched two generic drugs a generic version of Roche's anti-osteoporosis drugand another for acidity and heartburn whereas Sun pharma launched a nasal spray for allergic rhinitis in the USA.
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