APP currently markets Oxaliplatin for Injection (lyophilized) under a previously approved ANDA for Fresenius Kabi Oncology. APP Pharmaceuticals and Fresenius Kabi are members of the Fresenius Kabi Group of companies.
According to APP, 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.
Eloxatin is approved for the adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced carcinoma of the colon or rectum.
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