Mylan Inc. (Nasdaq: MYL) today announced that it has launched Capecitabine Tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers.
CEO Heather Bresch commented, "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."
Capecitabine Tablets USP, 150 mg and 500 mg, had U.S. sales of approximately $773.8 million for the 12 months ending June 30, 2014, according to IMS Health.
Currently, Mylan has 296 ANDAs pending FDA approval representing $106 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.