FDA Approves Generic Capecitabine

Zosia Chustecka

September 18, 2013

The first generic version of the oral chemotherapy agent capecitabine has been approved by the US Food and Drug Administration (FDA).

Capecitabine, marketed as Xeloda by Roche, is approved for the treatment of metastatic colorectal and breast cancer. According to a Bloomberg report, it generated sales of $1.6 million in 2012.

The generic capecitabine product, from Teva Pharmaceuticals, will be available as 150 mg and 500 mg doses.

"This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options," commented Kathleen Uhl MD, acting director of the Office of Generic Drugs at the FDA Center for Drug Evaluation and Research.

Capecitabine carries a boxed warning about a potential interaction with warfarin, which may increase levels of warfarin in the blood, leading to serious adverse effects.

Adverse effects reported with capecitabine include diarrhea, vomiting, nausea, mouth sores, hand–foot syndrome, and fever or infection, according to the FDA.


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