The FDA approved Avycaz, a new antibacterial drug product, to treat adults with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including kidney infections, who have limited or no alternative treatment options.
“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," 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.
Avycaz is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product. This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now title of the FDA Safety and Innovation Act.
It contains two drugs: ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, to help extend bacterial resistance.
Avycaz is distributed by Forest Pharmaceuticals Inc., a subsidiary of Forest Laboratories Inc. based in Cincinnati, Ohio.
