Fresenius Kabi USA, LLC – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Fresenius Kabi USA, LLC, for their New Drug Application (NDA 215818), dated April 25, 2025. The FDA determined that the application cannot be approved in its current form due to several outstanding deficiencies. While specific details in the nonclinical and product quality sections were not provided, these areas require further attention. The FDA deferred comments on the proposed prescribing information and carton/container labeling, stating that these would be reviewed once other issues are resolved, and advised the company to use available labeling resources and submit updates in a structured format. The proprietary name was conditionally acceptable but must be resubmitted after all deficiencies are addressed. A critical requirement is a comprehensive safety update, demanding detailed data from all clinical and nonclinical studies, analysis of safety profile changes, combined adverse event tabulations, summaries for serious adverse events and trial discontinuations, and updated exposure information. Fresenius Kabi USA, LLC must fully address all identified deficiencies and resubmit the application within one year for a new review cycle. The product cannot be legally marketed until it receives official FDA approval.