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# FDA Accepts NDA for Tetraphase Pharmaceuticals Antibiotic
- URL: https://www.fdaweb.com/fda-accepts-nda-for-tetraphase-pharmaceuticals-antibiotic/
- Published: 2018-02-27T12:00:00.000Z
- Updated: 2026-09-14T23:25:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140861

FDA has accepted for review a Tetraphase Pharmaceuticals NDA for eravacycline for treating complicated intra-abdominal infections. The user fee review action target date was set for 8/28\. The submission includes data from the IGNITE1 and IGNITE 4 Phase 3 clinical trials and showed that twice-daily eravacycline was well tolerated and achieved high clinical cure rates in patients with complicated intra-abdominal infections, the company says. “Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators — ertapenem in IGNITE1 and meropenem in IGNITE4 — for the primary efficacy endpoint of clinical response at the test-of-cure visit,” it says.

  
Eravacycline is a synthetic fluorocycline antibiotic being developed for treating complicated intra-abdominal infections and other serious infections, including those caused by multidrug-resistant pathogens that have been highlighted as urgent public health threats by both the World Health Organization and the U.S. Centers for Disease Control & Prevention.