Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.
The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
- The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
- Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
- The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
- Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.