Fresenius Kabi Pharmaceuticals Holding, Inc., announced that APP Pharmaceuticals will immediately begin marketing Anastrozole tablets in the US, after the US Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited. APP Pharmaceuticals and Fresenius Kabi Oncology Limited are members of the Fresenius Kabi Group of companies.
Anastrozole is therapeutically equivalent to the reference-listed drug Arimidex, which is currently marketed by the innovator AstraZeneca.
APP will market Anastrozole in 1 mg tablets. According to IMS data, 2009 sales of the branded product in the United States were approximately $916.8 million, with approximately 105 million tablets sold annually.
"The approval of Anastrozole further expands APP's product portfolio in the strategically important oncology segment," said John Ducker, president and chief executive officer of APP Pharmaceuticals. "We are delighted to be able to offer this important oral medication to new customers in the retail pharmacy channel."
Anastrozole is approved for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. It is also a first-line treatment for postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. In addition, Anastrozole is used in the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole.
APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anaesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008.
Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific.