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Capecitabine, first approved for treating metastatic breast cancer in 1998, now will be available in a generic formulation, the Food and Drug Administration announced Sept. 16.
The FDA has approved generic capecitabine (150 mg and 500 mg), manufactured by Teva Pharmaceuticals USA, the first generic formulation of this drug to be approved, the agency said in a written statement.
Capecitabine also has been approved for treating metastatic colorectal cancer (2001) and Dukes’ C colon cancer (2005). It is a nucleoside metabolic inhibitor with antineoplastic activity, and the trade formulation is marketed by Genentech as Xeloda.
Teva is not disclosing launch plans for the product at this time, a Teva spokesperson said.
To view the label for the trade formulation, click here.
*This story was updated 9/17/2013
Capecitabine, first approved for treating metastatic breast cancer in 1998, now will be available in a generic formulation, the Food and Drug Administration announced Sept. 16.
The FDA has approved generic capecitabine (150 mg and 500 mg), manufactured by Teva Pharmaceuticals USA, the first generic formulation of this drug to be approved, the agency said in a written statement.
Capecitabine also has been approved for treating metastatic colorectal cancer (2001) and Dukes’ C colon cancer (2005). It is a nucleoside metabolic inhibitor with antineoplastic activity, and the trade formulation is marketed by Genentech as Xeloda.
Teva is not disclosing launch plans for the product at this time, a Teva spokesperson said.
To view the label for the trade formulation, click here.
*This story was updated 9/17/2013
Capecitabine, first approved for treating metastatic breast cancer in 1998, now will be available in a generic formulation, the Food and Drug Administration announced Sept. 16.
The FDA has approved generic capecitabine (150 mg and 500 mg), manufactured by Teva Pharmaceuticals USA, the first generic formulation of this drug to be approved, the agency said in a written statement.
Capecitabine also has been approved for treating metastatic colorectal cancer (2001) and Dukes’ C colon cancer (2005). It is a nucleoside metabolic inhibitor with antineoplastic activity, and the trade formulation is marketed by Genentech as Xeloda.
Teva is not disclosing launch plans for the product at this time, a Teva spokesperson said.
To view the label for the trade formulation, click here.
*This story was updated 9/17/2013
