Actavis announced that the Food and Drug Administration (FDA) has approved Avycaz (ceftazidime/avibactam) for the treatment of adults with complicated intra-abdominal infections (cIAI) in combination with metronidazole and for patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
Avycaz is a combination of ceftazidime, a cephalosporin with in vitro activity against certain Gram-negative and Gram-positive bacteria, and avibactam, a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by Extended Spectrum Beta-Lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC) and AmpC producing pathogens.
The FDA approval was based on efficacy and safety data of ceftazidime for the treatment of cIAI and cUTI. Avycaz was studied in two Phase 2, randomized, blinded, active-controlled, multicenter trials, one each in cIAI and cUTI, including pyelonephritis.
Avycaz will be available as a 2g/0.5g strength in single-use vials in the second quarter of 2015.
For more information call (800) 432-8534 or visit Avycaz.com.