Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
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The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam. - The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
- “While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam.