Posted by Michael Wonder on 06 Jan 2019
Nabriva Therapeutics announces acceptance of the new drug application for intravenous Contepo to treat complicated urinary tract infections by FDA
4 January 2019 - PDUFA action date set for 30 June 2019.
Nabriva Therapeutics announced that the U.S. FDA has accepted the new drug application and granted a priority review for Contepo (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis.
The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. In addition to priority review, Contepo has been granted qualified infectious disease product and fast track designations by the FDA for the treatment of several serious infections, including cUTI.
