The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, to help extend bacterial resistance a new beta-lactamase inhibitor.

“The FDA is committed to making therapies available to treat patients with unmet medical need,” 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. “It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”

Avycaz is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435629.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery