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First generic version of Xeloda approved for breast colorectal cancers
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The FDA today approved the first generic version of capecitabine for treatment of patients with metastatic breast and colorectal cancers.
The administration authorized Teva Pharmaceuticals USA to market generic capecitabine (Xeloda, Hoffmann-LaRoche), an oral chemotherapy, in 150 mg and 500 mg pills.
“Generic drugs are important options that allow greater access to health care for all Americans,” Kathleen Uhl, MD, acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options.”
The most frequently reported adverse events reported in patients treated with capecitabine are nausea, vomiting, diarrhea, hand-foot syndrome, fever and infection, as well as swelling, redness or sores in the mouth, according to the FDA.
A boxed warning indicates capecitabine could intensify the effect of blood thinners such as warfarin, potentially causing serious side effects.