Mylan Inc. 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.(1)
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 Newsium.
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.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don’t take our word for it. See for yourself.