The US Food and Drug Administration (US FDA) has approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 milligram strengths.
“Generic drugs are important options that allow greater access to healthcare for all Americans,” said Kathleen Uhl, 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.”
In the clinical trials for Xeloda, the most commonly observed adverse reactions included: diarrhoea; 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. It is important that the prescriber know if the patient is also taking a medicine used to thin the blood, such as warfarin. Capecitabine could 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. Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
EP News Bureau – Mumbai
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