By IDSE News Staff
The FDA issued a Complete Response Letter to Venatorx Pharmaceuticals and Melinta Therapeutics regarding the new drug application for cefepime-taniborbactam under review as a potential treatment for adult patients with complicated urinary tract infections (cUTIs).
The FDA wants to see additional chemistry, manufacturing and controls (CMC), and related data about the drug, testing methods and manufacturing process.
The FDA’s letter did not identify clinical safety or