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# Melinta Therapeutics Priority Review for Baxdela sNDA
- URL: https://www.fdaweb.com/melinta-therapeutics-priority-review-for-baxdela-snda/
- Published: 2019-06-20T12:00:00.000Z
- Updated: 2026-09-15T01:33:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144386

FDA has accepted for priority review a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP). The agency has set a user fee review action target date of 10/24.

The submission is based on positive results from a Phase 3 study that compared Baxdela to moxifloxacin for treating CABP. The study results showed that Baxdela had “comparable efficacy to moxifloxacin for early clinical response and clinical outcome at test of cure,” the company says.

Baxdela was approved by FDA in 2017 for treating adult patients with acute bacterial skin and skin structure infections caused by certain susceptible bacteria.