APP Pharmaceuticals, Inc, a wholly-owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc, has received approval from the US Food and Drug Administration to market Oxaliplatin for Injection (lyophilized), 50 mg and 100 mg.

APP currently markets Oxaliplatin for Injection (lyophilized) under a previously approved ANDA for Fresenius Kabi Oncology Limited. APP Pharmaceuticals and Fresenius Kabi Oncology Limited are members of the Fresenius Kabi Group of companies.

Oxaliplatin for Injection is therapeutically equivalent to the reference-listed drug Eloxatin, which is currently marketed by the innovator sanofi-aventis. Under the terms of the previously announced settlement agreement with sanofi-aventis, which covers patents that apply to Eloxatin, APP Pharmaceuticals may market liquid and lyophilized Oxaliplatin products through at least June 30, 2010 and resume marketing the products on August 9, 2012.

According to IMS data, US sales of Eloxatin in 2009 were US$ 993 million. According to 2009 IMS data, combined US sales of Eloxatin and generic oxaliplatin were approximately US$ 1.35 billion1.

Eloxatin is approved for the adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumour and treatment of advanced carcinoma of the colon or rectum.

APP Pharma 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.

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.