FDA CRL - Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on December 11, 2024, for its New Drug Application (NDA 214610). The FDA has determined that the application cannot be approved in its current form due to several deficiencies. Key issues requiring resolution include unspecified nonclinical concerns, and reserved comments on proposed prescribing information, carton and container labeling until other issues are resolved. The proprietary names, previously conditionally acceptable, also need re-submission after all deficiencies are addressed.

A significant required action involves a comprehensive safety update, as stipulated by 21 CFR 314.50(d)(5)(vi)(b). This update must detail significant changes in the safety profile, present new and retabulated safety data from all studies, describe trial discontinuations, provide case report forms and narrative summaries for deaths or serious adverse events, and offer updated worldwide safety experience, including foreign labeling translations.

Fresenius Kabi is required to fully address all deficiencies within one year, under 21 CFR 314.110, by submitting a complete response. The company may also request a meeting with the FDA to discuss the necessary steps. The product cannot be legally marketed until FDA approval is granted.