Actavis, a generic drugs manufacturer based in Iceland, has received approval from the US Food & Drug Administration to market the generic breast cancer drug, Epirubicin Hydrochloride Injection, in the United States.
The drug will be Actavis’ second oncology drug introduced to the US this year.
Epirubicin Hydrochloride Injection, the generic to Pfizer’s Ellence, is prescribed to patients with evidence of axillary node tumours 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 was developed by Actavis scientists in Romania. It has been approved in 10 mg / 5 mL, 50 mg / 25 mL, and 200 mg / 100 mL configurations in the US.
Actavis is a leading generic drug manufacturer which operates in 40 countries around the world, of which the US is the company’s single largest market. Actavis’ US operations are located in New Jersey, Maryland, North Carolina and Florida.
For more information about Actavis and their products, visit www.actavis.com.