US FDA approves first generic Xeloda for colorectal and breast cancers

17 September 2013
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The US Food and Drug Administration approved the first generic version of Swiss drug major Roche’s (ROG: SIX) blockbuster Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum that has spread to other parts of the body and metastatic breast cancer, giving Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA) clearance to market a copy version of capecitabine in 150mg and 500mg strengths.

“Generic drugs are important options that allow greater access to health care for all Americans,” said Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, noting that “this medication is widely used by people living with cancer, so it is important to have access to affordable treatment options.”

Drug saw US sales of $706 million last year

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