Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.APP Pharmaceuticals, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals, has got FDA approval to market Oxaliplatin for injection (lyophilized), 50mg and 100mg.
Subscribe to our email newsletter
APP Pharma is a pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets.
APP Pharma said that it markets Oxaliplatin for injection (lyophilized) under a previously approved ANDA for Fresenius Kabi Oncology.
APP Pharma claimed that Oxaliplatin for injection is therapeutically equivalent to the reference-listed drug Eloxatin, which is currently marketed by the innovator Sanofi-aventis.
As per the terms of the previous settlement agreement with Sanofi-aventis, which covers patents that apply to Eloxatin, APP Pharma 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.