> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Melinta’s Baxdela Expanded Approval for Pneumonia
- URL: https://www.fdaweb.com/melintas-baxdela-expanded-approval-for-pneumonia/
- Published: 2019-10-25T12:00:00.000Z
- Updated: 2026-09-15T01:59:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145345

FDA has approved a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria. Approval was based on data from a Phase 3 study that compared Baxdela to moxifloxacin. The study results demonstrated that Baxdela met all key primary and secondary endpoints in the trial, the company says. In the intent-to-treat population, Baxdela met the FDA primary endpoint of statistical non-inferiority for “early clinical response” at 96 hours after therapy initiation (88.9%) compared to moxifloxacin (89.0%), it says. Baxdela was approved by the agency in 2017 for treating adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.