8 January 2020 - PDUFA action date set for 19 June 2020.

Nabriva Therapeutics announced that the U.S. FDA has acknowledged receipt of its new drug application resubmission for marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections.

In the acknowledgement letter for the resubmitted application, the FDA stated that Nabriva’s filing was a complete, class 2 response to the complete response letter the FDA issued on 30 April 2019.

Read Nabriva Therapeutics press release