Teva announces approval of Oxaliplatin injection

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced U.S. Food and Drug Administration (FDA) approval and launch of Oxaliplatin Injection.

Teva’s 505(b)(2) New Drug Application provides for the use of Oxaliplatin Injection, 50 mg/10 mL and 100 mg/20 mL for adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced colorectal cancer.

In June, the U.S. District Court for the District of New Jersey granted summary judgment in Teva's favor on the issue of non-infringement with regard to Debiopharm's U.S. Patent No. 5,338,874. The patent is listed in the Orange Book for Sanofi-Aventis' Eloxatin® (oxaliplatin injection) which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Sanofi-Aventis and Debiopharm have appealed this decision. Sanofi-Aventis has also sued the FDA seeking to rescind all approvals granted to date for Oxaliplatin Injection pending resolution of the outstanding appeal.


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