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# Venatorx/Melinta Antibiotic Gets Complete Response
- URL: https://www.fdaweb.com/venatorx-melinta-antibiotic-gets-complete-response/
- Published: 2024-02-23T12:00:00.000Z
- Updated: 2026-09-14T14:23:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156421

FDA has issued Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a beta-lactam/beta-lactamase inhibitor for treating adult patients with complicated urinary tract infections, including acute pyelonephritis caused by susceptible gram-negative microorganisms. The companies say the letter requested additional “chemistry, manufacturing, and controls and related data about the drug, testing methods, and manufacturing process.” They note that the agency did not identify clinical safety or efficacy issues in the submission, nor did it request any new clinical trials to support the approval.

“Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria,” the companies say. “Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, is being studied as a potential treatment option for patients with serious bacterial infections caused by antibiotic resistant gram-negative bacteria…”

Additionally, the combination has been granted FDA qualified infectious disease product and fast track designations.