The U.S. Food and Drug Administration (FDA) approved the first generic version of Xeloda today, granting Teva Pharmaceuticals USA approval to market generic capecitabine in two strengths: 150 milligrams and 500 milligrams. The oral chemotherapy pill is used to treat colorectal cancer that has spread to other parts of the body (‘metastatic’) as well as metastatic breast cancer.
“This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options,” Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, stated in a press release.
Xeloda, the brand formulation, is produced by Switzerland-based Roche Holding. One of the less common side effects is hand-foot syndrome. This chronic inflammation of the palms of the hands or soles of the feet may cause the skin to peel, bleed, or develop ulcers and blisters. In an article published in US News & World Report, one doctor noted that as a result of this particular side effect, people may even lose their fingerprints.
Bloomberg News reported that Xeloda, originally approved in 1998, generated $1.6 billion in sales for Roche last year. On its website for Xeloda, Roche offers financial support to patients. A global healthcare company, Roche has two core businesses: diagnostics and pharmaceuticals. The company has several personalized healthcare products on the market and is seeking to delve more deeply into this area of medicine.
The National Cancer Institute estimates that 142,820 people will be diagnosed with either colon or rectum cancer in 2013, while roughly 232,300 women will be diagnosed with breast cancer. Colorectal cancer is the fourth most common cancer in men, after skin, prostate, and lung cancer, and it is also the fourth most common cancer in women, after skin, breast, and lung cancer. A common symptom of colorectal cancer is a change in bowel habits.
A global pharmaceutical company, Teva Pharmaceutical Industries Ltd. is the largest maker of generic pharmaceutical products with a product portfolio of more than 1,300 molecules. Headquartered in Israel, the company maintains a direct presence in about 60 countries worldwide.