Supplier News Breaks Archives
Mylan launches Xeloda generic
August 11th, 2014
PITTSBURGH – Mylan Inc. has released capecitabine tablets (150 mg and 500 mg), a treatment for cancer.
The company said Monday that it has received final approval from the Food and Drug Administration for the product, indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers.
Mylan's capecitabine tablets are a generic version of Xeloda tablets from Genentech.
"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," stated Mylan chief executive officer Heather Bresch.
Capecitabine tablets 150 mg and 500 mg had U.S. sales of $773.8 million for the 12 months ended June 30, according to IMS Health data cited by Mylan.