FDA CRL - Fresenius Kabi USA, LLC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Fresenius Kabi USA, LLC regarding its Biologics License Application (BLA 761275) for MSB11456 (single-dose prefilled syringe, autoinjector, and vials) under section 351(k) of the Public Health Service Act. The FDA determined the application could not be approved in its current form, primarily due to unresolved deficiencies identified during inspections of manufacturing facilities, including Fresenius Kabi Austria GmbH. Satisfactory resolution of these facility-related issues is a prerequisite for approval. Furthermore, the FDA requires a comprehensive safety update detailing any significant changes in the safety profile, integration of new nonclinical and clinical study data, comparison of adverse event frequencies, and case report forms for deaths or serious adverse events. Fresenius Kabi must also present updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. While not immediate approvability issues, comments on proposed prescribing information and carton/container labeling are reserved until the primary deficiencies are addressed. The proprietary name, "Tyenne," was acceptable but needs resubmission with the updated application. Fresenius Kabi is required to resubmit the application, addressing all identified deficiencies, within one year. The company may also request a meeting with the FDA to discuss the necessary steps for approval.