Posted by Michael Wonder on 01 May 2019
Nabriva Therapeutics receives complete response letter from FDA on NDA for intravenous Contepo (fosfomycin) for injection
30 April 2019 - Issues related to facility inspections and manufacturing deficiencies at one contract manufacturer.
Nabriva Therapeutics announced today that it received a complete response letter from the U.S. FDA for the new drug application seeking marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
The letter 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.
