Posted by Michael Wonder on 21 Dec 2019
Nabriva Therapeutics resubmits new drug application for intravenous Contepo (fosfomycin) for Injection
20 December 2019 - Nabriva anticipates a six month review period by the Food and Drug Administration.
Nabriva Therapeutics announced today that it has resubmitted its New Drug Application (NDA) to the U.S. FDA for Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections, including acute pyelonephritis.
The NDA for Contepo was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in April 2019. The CRL stated that the FDA was unable to approve the NDA in its present form based on issues related to facility inspections and manufacturing deficiencies at one of the Company’s contract manufacturers. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of Contepo.
