Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam

VenatoRx Pharmaceuticals

23 February 2024 - No clinical safety or efficacy issues identified.

Venatorx Pharmaceuticals and Melinta Therapeutics announced today that the US FDA issued a complete response letter regarding the new drug application for cefepime-taniborbactam, a beta-lactam/beta-lactamase inhibitor combination antibiotic under review as a potential treatment for adult patients with complicated urinary tract infections, including acute pyelonephritis caused by susceptible gram negative microorganisms.

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Michael Wonder

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Michael Wonder