Nabriva Therapeutics received a CRL from the FDA for Contepo

Nabriva Therapeutics plc announced that it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) seeking marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA. Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of Contepo.