Posted by Michael Wonder on 01 Dec 2022
Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant strains, which have been identified by the CDC as an urgent global public health threat.
Innoviva today announced that the US FDA has accepted for priority review the new drug application for SUL-DUR, an investigational drug for the treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex, including multi-drug resistant and carbapenem-resistant strains.
The Agency is currently planning to hold an advisory committee meeting to discuss this application. The target PDUFA date is 29 May 2023.
