2 October 2017 - Application seeks to expand label to include an indication and phase 3 data for the treatment of patients with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Allergan today announced the U.S. FDA has accepted a supplemental n ew drug application for Avycaz (ceftazidime and avibactam) for priority review. The filing seeks to expand the current indications for AVYCAZ to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients based on positive results from a Phase 3 clinical trial evaluating Avycaz for the treatment of patients with HABP/VABP. 

The FDA granted priority review status to the application based on the previous Qualified Infectious Disease Product designation for Avycaz, and is expected to take action on the filing in the first quarter of 2018.

Read Allergan press release