PRESS RELEASE: APP Receives Tentative FDA Approval for Irinotecan Hydrochloride
APP Receives Tentative FDA Approval for Irinotecan Hydrochloride
Injection, 20 mg/mL Packaged in 2 mL and 5 mL Single-Use Vials
SCHAUMBURG, Ill. -- Oct. 5, 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(R) 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.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company's hospital and clinic-based products business, Abraxis Pharmaceutical Products (APP) is expected to be known as APP Pharmaceuticals subsequent to the close of the previously announced separation of the proprietary business from APP. APP develops, manufactures and markets one of the broadest portfolios of injectable products in the industry. Abraxis trades on the Nasdaq Global Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com or www.appdrugs.com.