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Mylan launches generic capecitabine tablets

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Mylan has launched 150 mg and 500 mg capecitabine tablets following receipt of its final ANDA approval from the FDA, according to a press release.

The product is a generic version of Xeloda (Genentech) indicated as a monotherapy, adjuvant therapy and combination therapy for certain types of colon, colorectal and breast cancers. The 150 mg and 500 mg capecitabine tablets had an estimated $773.8 million in U.S. sales for the year ending June 30, according to IMS Health, the release said.

“The approval of this product, one of a number of key approvals that had been pending with FDA, adds an important product to our broad and growing oncology franchise,” Heather Bresch, CEO of Mylan, a global pharmaceutical company with a portfolio of more than 1,300 generic drugs, said in the release. “We look forward to bringing a lower cost generic version of this product to patients.”

The company currently has 296 ANDAs pending FDA approval, which represent $106 billion in annual sales, according to IMS Health, according to the release.