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.

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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.

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