FDA approves antibacterial drug Avycaz

SILVER SPRING, Md. — Avycaz (ceftazidime-avibactam), distributed by Forest Labs, has received approval from the Food and Drug Administration, the agency on Thursday reported.  



According to the FDA, Avycaz is used to treat adults with intra-abdominal infections in combination with metronidazole and complicated urinary tract infections (including kidney infections) who have limited options for treatment. 

 

Avycaz is the fifth approved antibacterial drug to be designated as a qualified infection disease product. A QIDP designation is usually granted to products that treat serious or life-threatening infections. Because of this designation the drug was given a priority review, expediting the review of the drug's application. 

 

“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.”