APP Pharmaceuticals Receives Approval For Lyophilized Oxaliplatin For Injection

Main Category: Colorectal Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 09 Jun 2010 - 1:00 PDT

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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced it received approval from the U.S. 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 (NSE: FKONCO, BSE: 532545). 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, U.S. sales of Eloxatin® in 2009 were $993 million1. According to 2009 IMS data, combined U.S. sales of Eloxatin® and generic oxaliplatin were approximately $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 tumor and treatment of advanced carcinoma of the colon or rectum.

About APP Pharmaceuticals, Inc.

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, anesthetic/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. For more information about APP Pharmaceuticals, Inc., please visit the company's Web site at http://www.APPpharma.com.

1 Per IMS Dataview © IMS HEALTH as of December 31, 2009

Source
Fresenius Kabi AG

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