The Food and Drug Administration (FDA) has 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, a new beta-lactamase inhibitor.
“The FDA is committed to making therapies available to treat patients with unmet medical need,” says Edward Cox, MD, MPH, 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.
As part of its QIDP designation, Avycaz was given priority review, which provides an expedited review of the drug’s application. The QIDP designation also qualifies Avycaz for an additional five years of marketing exclusivity to be added to the five-year exclusivity period provided by the Food, Drug, and Cosmetic Act.
The determination of efficacy of Avycaz was supported in part by the findings of the efficacy and safety of ceftazidime for the treatment of cIAI and cUTI. The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was studied in two Phase 2 trials, one each in cIAI and cUTI. Both trials were not designed with any formal hypotheses for inferential testing against the active comparators.
The most common side effects include vomiting, nausea, constipation and anxiety. Health care professionals should inform patients of these risks and also advise that decreased efficacy, seizures and other neurologic events were seen in patients with poor kidney function (renal impairment). Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.
Avycaz is distributed by Forest Pharmaceuticals Inc., a subsidiary of Forest Laboratories Inc. based in Cincinnati, Ohio.
Source: FDA
CDC Urges Vigilance: New Recommendations for Monitoring and Testing H5N1 Exposures
July 11th 2025With avian influenza A(H5N1) infections surfacing in both animals and humans, the CDC has issued updated guidance calling for aggressive monitoring and targeted testing to contain the virus and protect public health.
IP LifeLine: Layoffs and the Evolving Job Market Landscape for Infection Preventionists
July 11th 2025Infection preventionists, once hailed as indispensable during the pandemic, now face a sobering reality: budget pressures, hiring freezes, and layoffs are reshaping the field, leaving many IPs worried about their future and questioning their value within health care organizations.
A Helping Hand: Innovative Approaches to Expanding Hand Hygiene Programs in Acute Care Settings
July 9th 2025Who knew candy, UV lights, and a college kid in scrubs could double hand hygiene adherence? A Pennsylvania hospital’s creative shake-up of its infection prevention program shows that sometimes it takes more than soap to get hands clean—and keep them that way.