Teva has announced the FDA approval and launch of Oxaliplatin Injection. Teva’s 505(b)(2) New Drug Application provides for the use of Oxaliplatin Injection, 50mg/10ml and 100mg/20ml, 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.
Earlier in June, the US 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 US Patent No. 5338874. The patent is listed in the Orange Book for Sanofi-Aventis’ Eloxatin (oxaliplatin injection). Sanofi-Aventis and Debiopharm appealed this decision. Sanofi-Aventis also sued the FDA seeking to rescind all approvals granted to date for Oxaliplatin Injection pending resolution of the outstanding appeal.