FDA CRL - Venatorx Pharmaceuticals Inc

The FDA issued a Complete Response Letter (CRL) for New Drug Application (NDA) 217556 to Venatorx Pharmaceuticals, Inc., regarding their co-packaged cefepime and taniborbactam for intravenous use. The CRL indicates the application cannot be approved in its current form due to several deficiencies. While specific details for Product Quality and Nonclinical areas were not provided in the document, these were noted as requiring attention. Key issues included deficiencies in both the Prescribing Information and Carton and Container Labeling, where submitted materials did not fully meet regulatory standards and prior discussion comments remained unaddressed, violating regulations such as 21 CFR 201.56 and 201.57. The proposed proprietary name was deemed conditionally acceptable, contingent on resolving all other deficiencies. A critical concern was raised in Clinical Pharmacology, where the proposed dosage for patients on intermittent hemodialysis was found to potentially result in higher than acceptable taniborbactam exposures. Required actions for resubmission include addressing all identified issues, updating and reformatting labeling according to FDA guidelines (including Structured Product Labeling), providing supportive analyses to determine an appropriate dosage for hemodialysis patients, and submitting a comprehensive safety update as per 21 CFR 314.50(d)(5)(vi)(b). The document did not specify inspection dates.