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news.APP Pharmaceuticals has received final approval from the FDA of its abbreviated new drug application or ANDA for irinotecan hydrochloride injection, 40mg/2mL and 100mg/5mL.
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The drug is the generic equivalent of Pfizer’s Camptosar injection, a chemotherapy drug used to treat advanced cancer of the large intestine and rectum. It is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic colorectal cancer. APP has immediately commenced marketing and shipping the product.
Tom Silberg, president of APP, said: “Since receiving tentative approval for this product in October 2007, we have worked to secure a number of contracts and are pleased to be one of the first pharmaceutical companies to market and ship irinotecan in the US. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008.”