WASHINGTON (AP) — The Food and Drug Administration has approved a new antibiotic from Durata Therapeutics to treat adults with common skin infections often acquired in U.S. hospitals.
Regulators approved the intravenous drug Dalvance to treat bacterial skin infections caused by common bacteria, including antibiotic-resistant strains of those germs.
The FDA gave Dalvance an expedited review, under a 2012 law designed to encourage research and development of new antibiotics. Under the measure, Chicago-based Durata will receive an additional five years of exclusive marketing rights on the drug.
The FDA said it approved Dalvance based on two trials of nearly 1,300 patients with skin and skin structure infections.