Abraxis Pharmaceutical Products Receives FDA Approval for Epirubicin HCl Injection
SCHAUMBURG, Ill. -- Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, today announced approval from U.S. Food and Drug Administration (FDA) to market Epirubicin hydrochloride injection in four dosage forms. Two of the dosage forms (2mg/mL 5mL and 2mg/mL 75mL) are unique codes and are not currently available on the market. The remaining two dosage forms (2mg/mL 25mL and 2mg/mL 100mL) are marketed by the innovator, Pfizer Inc., as Ellence®. APP will package epirubicin in single dose vials and expects to launch in this fourth quarter of 2007. According to IMS data, sales of this product across all formulations and manufacturers were approximately $64 million in 2006.
Epirubicin belongs to a class of drugs called anthracyclines and is the foundation of many chemotherapy regimens. It is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement (cancer that has spread to the lymph nodes) following resection of primary breast cancer.
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-infective, critical care, oncology and anesthetic/analgesic products totaling over 400 dosage forms. Including those ANDAs pending with the FDA, APP currently has approximately 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 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 Abraxis. 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.