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news.APP Pharmaceuticals, a member of the Fresenius Kabi Group of companies, is set to begin marketing Oxaliplatin injection (liquid) in the US. APP currently markets the lyophilized product, Oxaliplatin for Injection, 50 mg and 100 mg.
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FDA granted approval to market Oxaliplatin Injection in two dosage strengths to Fresenius Kabi Oncology.
Oxaliplatin injection is therapeutically equivalent to Eloxatin, which is invented and marketed by Sanofi-aventis.
APP Pharma and Fresenius Kabi Oncology said that they may market liquid and lyophilised Oxaliplatin products through at least June 30, 2010 and resume marketing the products on August 9, 2012, as per the terms of settlement agreement with Sanofi-aventis regarding the patents that apply to Eloxatin.
APP Pharma is expected to market Oxaliplatin injection in 5mg/ml single dose vials, available in 10ml and 20ml vial sizes.
John Ducker, president and CEO of APP Pharma, said: “This approval enables APP to offer its customers a choice between the lyophilised product that APP Pharmaceuticals currently markets and a more convenient, ready to use liquid form.”