The U.S. Food and Drug Administration has approved Avycaz, an antibacterial drug for patients with complicated intra-abdominal infections or complicated urinary tract infections who have limited or no alternative treatment options.
Avycaz is distributed by Forest Pharmaceuticals, a subsidiary of Forest Laboratories in Cincinnati.
This is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product by the FDA, a label given to antibacterial products that treat serious or life-threatening infections. The QIDP label was created under the Generating Antibiotic Incentives Now part of the FDA Safety and Innovation Act.
With antibiotic resistance growing across the globe, the FDA urged clinicians to use Avycaz sparingly.
"It's important that the use of Avycaz be reserved to situations where there are limited or no alternative antibacterial drugs for treating a patient's infection," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.