Lead Product(s): Fosfomycin Trometamol
Therapeutic Area: Infections and Infectious Diseases
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2020
In the acknowledgement letter for the resubmitted NDA, the FDA stated that Nabrivaâ€™s filing was a complete, class 2 response to the complete response letter the FDA issued on April 30, 2019.