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# FDA Accepts 2 Melinta NDAs for Skin Infections
- URL: https://www.fdaweb.com/fda-accepts-2-melinta-ndas-for-skin-infections/
- Published: 2017-01-05T12:00:00.000Z
- Updated: 2026-09-14T21:58:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137646

FDA has accepted for priority review two Melinta Therapeutics NDAs for intravenous and oral Baxdela (delafloxacin) for treating patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant *Staphylococcus aureus* (MRSA), according to the company. The agency has set a user fee review target date of 6/19.

The submissions are based on data from two Phase 3 studies (studies 302 and 303) that evaluated intravenous and oral Baxdela monotherapy compared with vancomycin plus aztreonam combination therapy for the treatment of patients with ABSSSI. Both studies met the primary endpoints for efficacy, the company says.