FDA CRL - Fresenius Kabi USA, LLC

On February 27, 2026, the FDA issued a Complete Response Letter to Fresenius Kabi USA, LLC regarding New Drug Application (NDA) 214610 for an injectable emulsion consisting of amino acids, electrolytes, dextrose, and lipids. The FDA determined that the application could not be approved in its current form due to unresolved issues regarding nonclinical data and product quality. While specific inspection dates were not listed in the provided sections, the agency identified several deficiencies that must be addressed before the product can be legally marketed.

Operating under the regulatory framework of 21 CFR 314.110, the FDA requires Fresenius Kabi to provide a comprehensive safety update. This update must include new data from clinical trials, a worldwide safety summary, and detailed reports on any adverse events or patient withdrawals. Furthermore, the agency recommended a specific revision to the product's established name to align with industry safety standards and minimize potential medication errors. The FDA has deferred final comments on the proposed prescribing information and carton labeling until the primary deficiencies are corrected.

To move forward, the company must submit a complete resubmission within one year that addresses all identified concerns. Failure to do so may result in the application being considered withdrawn. Fresenius Kabi also has the option to request a formal meeting with the FDA to discuss the path toward approval.