Mylan launches capecitabine tabs
PITTSBURGH — Mylan announced the launch of capecitabine tablets USP in 150-mg and 500-mg dosage strengths. The drug is the generic version of Xeloda tablets from Genentech and is indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers, according to the company.
"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," said Heather Bresch, Mylan's CEO. "We look forward to bringing a lower cost generic version of this product to patients."
Capecitabine tablets had sales in the United States of approximately $773.8 million for the 12 months ending June 30, 2014, according to IMS Health data.
Twinlab Consolidation Corp. acquires Twinlab Corp. in strategic, employee-led buyout
FDA announces approval for Orbactiv
SILVER SPRING, Md. — The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections. The drug is administered intravenously.
“The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”
Orbactiv is marketed by the Medicines Co.