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FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers

Drug offers cheaper alternative to Xeloda (September 16)

The FDA has approved the first generic version of Xeloda (capecitabine, Genentech), an oral chemotherapy pill used to treat metastatic cancer of the colon or rectum, and metastatic breast cancer.

Teva Pharmaceuticals USA will market generic capecitabine in 150-mg and 500-mg strengths.

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

According to the National Cancer Institute, an estimated 1.6 million people in the U.S. will be diagnosed with cancer and 580,000 will die of the disease in 2013. It is estimated that 142,820 people will be diagnosed with, and 50,830 will die of, cancer of the colon and rectum this year. In addition, an estimated 232,340 women will be diagnosed with, and 39,620 women will die of, breast cancer.

In clinical trials of Xeloda (capecitabine), the most commonly observed adverse reactions included diarrhea; vomiting; nausea; pain, redness, swelling, or sores in the mouth; hand-and-foot syndrome (pain, swelling, or redness of the hands or feet that prevents normal activity); and fever or infection.

It is important that prescribers know whether patients are also taking medicines used to thin the blood, such as warfarin. Capecitabine could increase the effect of these drugs, possibly leading to serious side effects. Capecitabine has a boxed warning to alert health care professionals and patients about this risk.

Source: FDA; September 16, 2013.

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