FDA approves Allergan's sNDA for Avycaz (ceftazidime and avibactam) to include new phase III data in patients with complicated urinary tract infections, including pyelonephritis

Allergan

30 January 2017 - New clinical data for Avycaz demonstrates efficacy in complicated urinary tract infection patients including those with infections due to resistant Gram-negative pathogens.

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 two Phase 3 trials supporting the indication to treat patients with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.

Read Allergan press release

Michael Wonder

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Michael Wonder

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Outcome , Combination product , US