Indian drug firm Strides Arcolab 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.
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.
http://health.india.com/news/indian-firm-strides-acrolab-gets-fda-nod-for-generic-cancer-drug/
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