Posted by Michael Wonder on 19 Jun 2019
Melinta Therapeutics announces U.S. FDA acceptance of supplemental new drug application for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia
19 June 2019 - Application seeks to expand label to include an indication and phase III data for the treatment of adult patients with community-acquired bacterial pneumonia.
Melinta Therapeutics today announced the U.S. FDA has accepted a supplemental new drug application for Baxdela (delafloxacin) for priority review.
Through this process, the FDA has assigned a Prescription Drug User Fee Act action date (proposed review deadline) of 24 October 2019.
The application is based on positive results from a Phase III, randomised, double-blind, study that compared the efficacy and safety of Baxdela to moxifloxacin for the treatment of community-acquired bacterial pneumonia.
