Posted by Michael Wonder on 26 Oct 2019
Melinta Therapeutics announces U.S. FDA approval of supplemental new drug application for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia
25 October 2019 - Approval based on positive phase III trial results of Baxdela for treatment of CABP in Adults.
Melinta Therapeutics today announced the U.S. FDA has approved Baxdela (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria.
This supplemental approval follows FDA priority review based on the previous qualified infectious disease product designation, which provides certain incentives for the development of antibacterial and anti-fungal treatments for serious or life-threatening infections.
