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# FDA Accepts Priority Review NDA for Carbavance
- URL: https://www.fdaweb.com/fda-accepts-priority-review-nda-for-carbavance/
- Published: 2017-02-22T12:00:00.000Z
- Updated: 2026-09-14T22:07:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138042

FDA has accepted for priority review an NDA from the Medicines Co. for Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections (cUTIs). The submission is based on results from the pivotal Phase 3 TANGO 1 clinical trial in patients with cUTIs, which met both FDA and European Medicines Agency pre-specified primary endpoints, according to the company. “Carbavance also demonstrated statistical superiority over piperacillin-tazobactam with overall success in 98.4% of patients,” it says.

  
Carbavance is a combination of carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), administered as a fixed combination by intravenous infusion. It is being developed to treat serious gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently-available carbapenems.