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# FDA Approves 2 Melinta NDAs for Antibiotic
- URL: https://www.fdaweb.com/fda-approves-2-melinta-ndas-for-antibiotic/
- Published: 2017-06-20T12:00:00.000Z
- Updated: 2026-09-14T22:30:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138974

FDA has approved two Melinta Therapeutics NDAs for Baxdela (delafloxacin), indicated in adults for treating acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. The company describes Baxdela as a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin-resistant *Staphylococcus aureus*, and is available in both intravenous (IV) and oral formulations. The approvals were supported by two Phase 3 studies in patients with ABSSSI, demonstrating that IV and oral Baxdela monotherapy was statistically non-inferior to a combination of vancomycin plus aztreonam (primary endpoint: early clinical response at 48-72 hours).