FDA CRL - Unicycive Therapeutics Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Unicycive Therapeutics Inc. regarding their New Drug Application (NDA 218607) for oxylanthanum carbonate tablets. The FDA determined that the application cannot be approved in its present form. A primary reason for this decision stems from unresolved deficiencies identified during Current Good Manufacturing Practices (CGMP) and pre-approval inspections (PAI) of a manufacturing facility listed in the submission. The facility must provide satisfactory responses to these inspectional findings and demonstrate compliance with CGMP standards before the application can proceed. Reinspections may be necessary to confirm resolution. Additionally, the FDA reserved comments on the proposed prescribing information, carton, and container labeling until other issues are adequately addressed. The proposed proprietary name, though conditionally acceptable, must be resubmitted once all application deficiencies are resolved. Unicycive Therapeutics Inc. is also required to submit a comprehensive safety update. This update must include detailed data from all nonclinical and clinical studies, highlighting any significant changes or new findings in the safety profile. It requires re-tabulation of adverse events, comparison with original application data, updated exposure information, and a summary of worldwide safety experience, including English translations of foreign labeling. The company must resubmit the application, fully addressing all identified deficiencies, within one year to avoid potential withdrawal. The product cannot be legally marketed until formal approval is granted.