Strides Arcolab's anti-cancer injection gets nod from USFDA
New Delhi, July 19, 2012: The Indian pharma major Strides Arcolab recently said that it has received two approvals from the United States Food and Drug Administration (USFDA) or its new drug applications –ANDA – for Fluorouracil Injection USP in two strengths. It is worth noting here that the generic Fluorouracil Injection is used for treating several types of cancer.
The company also said that the approvals are in regards to the injections in the strengths of 50 mg / mL, packaged in 10 mL and 20 mL single-dose vials and 2.5g/50 mL and 5g/100 mL pharmacy bulk packages.
Fluorouracil fall under the category of drug shortage and the data from IMS suggests that the market for generic Fluorouracil is worth approximately at $14 million.
The company said that the product is part of its oncology portfolio licensed to Pfizer in the US and it is expected to be launched in the short run. For the record, Fluorouracil can be used to cure several type of cancer including colon, rectum and head and neck.