23 June 2016 - Label now includes Phase 3 clinical data evaluating the safety and efficacy of Avycaz (in combination with metronidazole) in patients with complicated intra-abdominal infections.

Allergan today announced the U.S. FDA has approved the company's supplemental new drug application to update the label for Avycaz (ceftazidime and avibactam) with clinical data from a Phase 3 trial evaluating the safety and efficacy of Avycaz, in combination with metronidazole, for the treatment of complicated intra-abdominal infections caused by designated susceptible microorganisms.

The approved label also contains data from a subset of patients in this trial with infections due to ceftazidime-nonsusceptible pathogens, as well as a subset who had pathogens producing certain extended-spectrum beta-lactamases.

View Allergan press release

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