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news.Abraxis Pharmaceutical Products, the hospital-based business of Abraxis BioScience, has received FDA approval to market the chemotherapy drug epirubicin hydrochloride in four doses.
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Two of the dosage forms (2mg/mL 5mL and 2mg/mL 75mL) are unique codes and are not currently available in the market. The remaining two dosage forms (2mg/mL 25mL and 2mg/mL 100mL) are marketed by Pfizer as Ellence.
Abraxis Pharmaceutical Products (APP) will package epirubicin in single dose vials and expects to launch it in Q4 of 2007. 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.