Feb. 27, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Irinotecan Hydrochloride Injection, 40 mg/2mL and 100mg/5mL, the generic equivalent of Camptosar(R) Injection manufactured by Pfizer Inc. APP has immediately commenced marketing and shipping the product. APP's irinotecan is AP-rated, bar-coded and latex-free. According to IMS data, sales of Camptosar(R) in the United States were approximately $556 million in 2007.
Pfizer's Camptosar(R) Injection is 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. The drug is also indicated for patients with metastatic colorectal cancer whose disease has recurred or progressed following initial fluorouracil-based therapy.
"Irinotecan is a large market opportunity," said Tom Silberg, President of APP. "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 U.S. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008."
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