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news.US-based pharmaceutical firm Mylan has launched Capecitabine Tablets USP, 150mg and 500mg, the generic version of Genentech's Xeloda Tablets.
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The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for the product, which is indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers.
Mylan CEO Heather Bresch 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.
"We look forward to bringing a lower cost generic version of this product to patients," Bresch said.
According to IMS Health, Capecitabine Tablets USP, 150mg and 500mg, had US sales of about $773.8m for the 12 months ending 30 June 2014.
At present, the company has 296 ANDAs pending FDA approval representing $106bn in annual brand sales.
The company said that 43 of these pending ANDAs are potential first-to-file opportunities, representing $25bn in annual brand sales, for the 12 months ending 31 December 2013.