Unicycive Therapeutics Inc. · lettre de réponse complète (NDA 218607)

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¢ yy U.S. FOOD & DRUG ADMINISTRATION NDA 218607 COMPLETE RESPONSE Unicycive Therapeutics Inc. Attention: Shalabh Gupta, MD, MPA President & CEO 1975 W. El Camino Real, Suite 204 Mountain View, CA 94040 Dear Dr. Gupta: Please refer to your new drug application (NDA) dated and received August 28, 2024, and your amendments, submitted pursuant to for oxylanthanum carbonate tablets. We acknowledge receipt of your amendment dated December 29, 2025, which constituted a complete response to our June 27, 2025, action letter. We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. FACILITY INSPECTIONS Following a Current Good Manufacturing Practices (CGMP) inspection of me listed in this application, FDA conveyed deficiencies ‘o the representative of the facility. The facility should provide satisfactory responses to hese deficiencies to the FDA office indicated on the FDA Form 483 prior to your complete response. The facility's satisfactory responses are dependent on FDA's determination that the facility has come into compliance with CGMP and may require re- inspection of the facility. The deficiencies identified during the inspection may not be specific to your pending application; therefore, you should coordinate with the facility for imely resolution. Your complete respo

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