FDA Approves Generic Version of Xeloda

The U.S. Food and Drug Administration has approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill that's used to treat colorectal cancer and breast cancers that may have metastasized to other parts of the body.

Teva Pharmaceuticals USA has gained FDA approval in order to market generic medications in 150 and 500 milligram strengths, according to a recent announcement from the FDA.

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

The U.S. Centers for Disease Control and Prevention shows that colorectal cancer is the second leading cause of cancer related deaths in the United States and the third most common type of cancer in both men and women.

The National Cancer Institute also estimates that 1.6 million people in the United States will be diagnosed with this type of cancer and 580,000 will die from it in 2013 alone. It's also estimated that 142,820 people will be diagnosed with it and 50,830 will die of cancer of the colon and rectum in 2013. Lastly, close to 232,340 women will be diagnosed with and 39,620 women will die of cancer of the breast in 2013. 

The most commonly observed adverse reactions to this medication include the following, via the organization: diarrhea; vomiting; nausea; pain, redness, swelling, or sores in the mouth; hand-and-foot syndrome (pain, swelling, or redness of hands or feet that prevents normal activity); and fever or infection.

The FDA also notes that it's important for any medical personnel prescribing the drug to be aware of medications that the patient is currently taking to thin the blood, including warfarin, as more serious side-effects may result from interaction. 

For more information regarding the original form of Xeloda, click here.