Posted by Michael Wonder on 02 Jan 2018
Achaogen announces FDA acceptance of new drug application with priority review for plazomicin for treatment of complicated urinary tract infections and bloodstream infections
2 January 2018 - FDA sets action date of 25 June 2018.
Achaogen today announced that the U.S. FDA has accepted for review the company's new drug application for plazomicin for the treatment of complicated urinary tract infections, including pyelonephritis, and bloodstream infections due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options.
FDA has granted the NDA priority review and set a target action date under the Prescription Drug User Fee Act of 25 June 2018. Achaogen also intends to submit an application for marketing authorisation in the European Union in 2018.
