FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers


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The U.S. Food and Drug Administration (FDA) has approved the first generic version of capecitabine (Xeloda), an oral chemotherapy agent used in the treatment of metastatic colorectal cancer and breast cancers. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 mg strengths.

Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

“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.”

Adverse Effects

In the clinical trials for capecitabine, the most commonly observed adverse reactions included diarrhea; vomiting; nausea; pain, redness, swelling, or sores in the mouth; hand-and-foot syndrome; and fever or infection.

It is important that the prescriber know if the patient is also taking an anticoagulant such as warfarin, as capecitabine can increase the effect of this medicine, possibly leading to serious side effects. Capecitabine has a boxed warning to alert health-care professionals and patients about this risk.

Information about the availability of generic capecitabine can be obtained from Teva. ■



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