Actavis has received approval from the US Food & Drug Administration to market Epirubicin Hydrochloride Injection.

Epirubicin Hydrochloride Injection, the generic to Pfizer’s Ellence®, has been approved in 10 mg / 5 mL, 50 mg / 25 mL, and 200 mg / 100 mL configurations and is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumour involvement following resection of primary breast cancer.

Annual US sales of brand and generic Epirubicin HCl Injection were US$17.5 million for the 12 months ending June 2008 according to IMS Health data.

Actavis currently markets over 50 hospital products worldwide, with a focus on oncology products and a growing range of anti-infectives, local anesthetics and analgesics.

Epirubicin HCl Injection, is developed by Actavis scientists in Romania. It's Actavis' second injectable oncology product in the United States; Actavis received FDA approval for Irinotecan Hydrochloride Injection in February.