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# Nabriva NDA for Urinary Tract Infections Antibiotic
- URL: https://www.fdaweb.com/nabriva-nda-for-urinary-tract-infections-antibiotic/
- Published: 2019-01-04T12:00:00.000Z
- Updated: 2026-09-15T00:52:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143088

FDA has accepted a Nabriva Therapeutics NDA and granted a priority review for Contepo (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The agency has set a 6/30 review action target date. The 505(b)(2) submission is supported by data from the Phase 2/3 ZEUS clinical trial, which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis. Nabriva describes Contepo as an intravenous investigational antibiotic with “a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant strains such as \[extended spectrum beta-lactamases\]-producing *Enterobacteriaceae*.