FDA approves Teva's generic version of Roche cancer drug Xeloda

Sept 16 Mon Sep 16, 2013 2:07pm EDT

Sept 16 (Reuters) - The U.S. Food and Drug Administration said it approved Teva Pharmaceutical Industries Ltd's generic version of Roche Holding AG's cancer drug Xeloda.

Teva Pharmaceuticals USA, a unit of the generic drugmaker, will market 150 and 500 milligram doses of the oral drug, named capecitabine. ()

The drug, like Xeloda, will have a boxed warning about an increased risk of bleeding in patients who are on blood thinners .

Xeloda, which treats colorectal cancer and breast cancer that spreads to other body parts, accounted for revenue of $1.52 billion swiss francs ($1.65 billion) last year, making it Roche's fifth-largest drug.

The drug was to lose its patent protection at the end of this year. Privately held Indian drugmaker Intas Pharmaceuticals signed an agreement in June with Roche to sell generic Xeloda in the United States before it lost exclusivity.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.