www.fdanews.com/articles/175532-fda-issues-allergan-priority-review-for-expanded-avycaz-label
FDA Issues Allergan Priority Review for Expanded Avycaz Label
March 1, 2016
The FDA granted priority review to Dublin-based Allergan for expanded labeling for Avycaz to treat complicated intra-abdominal infections and infections initiated by ceftazidime-nonsusceptible pathogens.
The priority review status is based on a previous qualified infectious disease product designation for Avycaz.
The FDA gave the go ahead to Avycaz in February 2015 to treat adult patients with cIAI in combination with metronidazole and complicated urinary tract infections.