Ireland-based Allergan (NYSE: AGN) has received approval from the US Food and Drug Administration (FDA) for the supplemental new drug application to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, it was reported on Friday.

The product was approved to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the susceptible Gram-negative microorganisms that include Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older.

This expanded use is based on positive results from a pivotal Phase three study assessing the efficacy and safety of Avycaz for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The supplemental new drug application received priority review from the FDA based on the Qualified Infectious Disease Product designation for the hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia indication.