Teva receives FDA approval for colon cancer generic

JERUSALEM The Food and Drug Administration has approved a generic version of a colon cancer treatment.

Teva Pharmaceutical Industries announced last week the approval and launch of oxaliplatin, an injectable drug, in the 50 mg per 10 milliliter and 100 mg per 20 milliliter strengths. The drug is a generic version of Debiopharm’s and Sanofi-Aventis’ Eloxatin and is approved as an 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 ruled in Teva’s favor, finding that Teva did not infringe U.S. Patent No. 5,338,874, Debiopharm’s patent on Eloxatin. Sanofi and Debiopharm have appealed the decision, and Sanofi has sued the FDA seeking to rescind all approvals of generic oxaliplatin pending resolution of the appeal.

Eloxatin had sales of $1.3 billion in the United States last year, according to IMS Health data.

Login or Register to post a comment.