Teva’s Generic Xeloda Approved for Colorectal, Breast Cancers

The FDA announced the approval of Teva’s Capecitabine Tablets, the first generic version of Roche’s Xeloda.

Xeloda is a fluoropyrimidine indicated for first-line treatment of metastatic colorectal carcinoma when fluoropyrimidine therapy alone is preferred; and as adjuvant treatment of Dukes’ C colon cancer after complete resection of the primary tumor when fluoropyrimidine therapy alone is preferred.

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Xeloda is also indicated for metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel when further anthracycline therapy is not indicated; and with docetaxel for metastatic breast cancer after failure of prior anthracycline-containing regimen.

Teva has gained approval to market Capecitabine 150mg and 500mg strength tablets.

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