FDA approves generic Xeloda
FDA Approves First Generic Version of Xeloda
HealthDay News -- The FDA has approved the first generic version of the oral chemotherapy drug Xeloda (capecitabine) to treat metastatic colorectal or breast cancers.
This year an estimated 142,820 people will be diagnosed with cancer of the colon/rectum, and 50,830 are predicted to die from the disease, according to the U.S. National Cancer Institute. An estimated 232,340 women will be diagnosed with cancer of the breast this year, and some 39,620 will die from it.
Generic capecitabine will be available in 150 mg and 500 mg doses. The most common side effects in clinical trials are diarrhea, vomiting and nausea, as well as oral pain, redness, swelling and sores, the FDA said.
Other adverse events include fever and infection. The drug will come with a boxed warning to avoid concomitant use with blood thinners.
The agency stressed that approved generics have the same high quality and strength as their brand-name counterparts.
License to produce the generic drug was given to Israel-based Teva Pharmaceuticals. The brand name drug is produced by the Swiss pharmaceutical firm Roche.