FDA News

FDA Approves APP for Irinotecan Hydrochloride Injection

(Oct 08, 2007)-- Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced the tentative approval from U.S. Food and Drug Administration (FDA) to market Irinotecan Hydrochloride Injection, 20 mg/mL, 2 mL, and 5 mL, the generic equivalent of Camptosar Injection manufactured by Pfizer Inc. APP will package this product in 40 mg/2mL and 100 mg/5mL single-use vials. According to IMS data, sales of this product were approximately $527 million in 2006.

As one of the only companies to receive a tentative approval, APP is in the process of securing contracts and expects to commence marketing of this product upon patent expiry in February 2008.

Irinotecan HCI 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 carcinoma of the colon or rectum. Irinotecan can also be used when the cancer has come back or progressed following initial fluorouracil-based therapy.

APP manufactures and markets one of the most comprehensive injectable portfolios of products to the U.S. hospital-based market. The current injectable portfolio is comprised of anti-infectives, critical care, oncology and anesthetic/analgesic products totaling over 400 dosage forms. Including those ANDAs pending with the FDA, APP currently has over 60 product candidates in various stages of development.

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