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    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
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  "results": [
    {
      "letter_date": "06/29/2026",
      "approver_title": null,
      "file_name": "CRL_NDA218607_20260629.pdf",
      "letter_year": "2026",
      "approval_status": "Unapproved",
      "approver_name": "Center for Drug Evaluation and Research",
      "approver_center": [],
      "company_rep": "Shalabh Gupta, MD, MPA",
      "company_address": "1975 W. El Camino Real, Suite 204\nMountain View, CA 94040",
      "company_name": "Unicycive Therapeutics Inc.",
      "text": "¢ yy U.S. FOOD & DRUG\n\nADMINISTRATION\n\nNDA 218607\nCOMPLETE RESPONSE\n\nUnicycive Therapeutics Inc.\nAttention: Shalabh Gupta, MD, MPA\nPresident & CEO\n\n1975 W. El Camino Real, Suite 204\nMountain View, CA 94040\n\nDear Dr. Gupta:\n\nPlease refer to your new drug application (NDA) dated and received August 28, 2024,\nand your amendments, submitted pursuant to\nfor oxylanthanum carbonate tablets.\n\nWe acknowledge receipt of your amendment dated December 29, 2025, which\nconstituted a complete response to our June 27, 2025, action letter.\n\nWe have completed our review of this application, as amended, and have determined\nthat we cannot approve this application in its present form. We have described our\nreasons for this action below and, where possible, our recommendations to address\nthese issues.\n\nFACILITY INSPECTIONS\nFollowing a Current Good Manufacturing Practices (CGMP) inspection of me\n\nlisted in this application, FDA conveyed deficiencies\n‘o the representative of the facility. The facility should provide satisfactory responses to\nhese deficiencies to the FDA office indicated on the FDA Form 483 prior to your\ncomplete response. The facility's satisfactory responses are dependent on FDA's\ndetermination that the facility has come into compliance with CGMP and may require re-\ninspection of the facility. The deficiencies identified during the inspection may not be\nspecific to your pending application; therefore, you should coordinate with the facility for\nimely resolution. Your complete response should include the date(s) of the facility's\nresponse(s) to the FDA Form 483. Please refer to Compliance Program CP 7356.002\nor guidance on post inspection activities. Following resolution of the CGMP inspection,\nFDA may need to conduct a pre-approval inspection (PAI) of the facility. Satisfactory\noutcomes of both the PAI and the CGMP surveillance inspections will be needed prior\n0 approval of the application.\n\nReference ID: 5825414\n\nNDA 218607\nPage 2\n\nPRESCRIBING INFORMATION\n\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate. We encourage you to review the labeling review resources on the\nPrescription Drug Labeling Resources! and Pregnancy and Lactation Labeling Final\nRule? websites, including regulations and related guidance documents and the Selected\nRequirements for Prescribing Information (SRPI) - a checklist of important format items\nfrom labeling regulations and guidances.\n\nIf you revise labeling, use the SRPI checklist to ensure that the Prescribing Information\nconforms with format items in regulations and guidances. Your response must include\nupdated content of labeling [21 CFR 314.50(I)(1)(i)] in structured product labeling (SPL)\nformat as described at FDA.gov.$\n\nCARTON AND CONTAINER LABELING\n\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate.\n\nPROPRIETARY NAME\n\nPlease refer to our correspondence dated March 25, 2026, which addresses the\nproposed proprietary name, //\"). This name was found conditionally acceptable\npending approval of the application in the current review cycle. Please resubmit the\nproposed proprietary name when you respond to all of the application deficiencies that\nhave been identified in this letter.\n\nSAFETY UPDATE\n\nWhen you respond to the above deficiencies, include a safety update as described at\n21 CFR 314.50(d)(5)(vi)(b). The safety update should include data from all nonclinical\nand clinical studies/trials of the product under consideration regardless of indication,\ndosage form, or dose level.\n\n(1) Describe in detail any significant changes or findings in the safety profile.\n(2) When assembling the sections describing discontinuations due to adverse\n\nevents, serious adverse events, and common adverse events, incorporate new\nsafety data as follows:\n\n1 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources\n\n2 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-\nfinal-rule\n\n3 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm\n\nU.S. Food and Drug Administration\n\nSilver Spring, MD 20993\n\nwww.fda.gov\n\nReference ID: 5825414\n\nNDA 218607\nPage 3\n\ne Present new safety data from the studies/clinical trials for the proposed\nindication using the same format as in the original submission.\n\ne Present tabulations of the new safety data combined with the original\napplication data.\n\ne Include tables that compare frequencies of adverse events in the original\napplication with the retabulated frequencies described in the bullet above.\n\ne For indications other than the proposed indication, provide separate tables for\nthe frequencies of adverse events occurring in Clinical trials.\n\n(3) Present a retabulation of the reasons for premature trial discontinuation by\nincorporating the drop-outs from the newly completed trials. Describe any new\ntrends or patterns identified.\n\n(4) Provide case report forms and narrative summaries for each subject who died\nduring a Clinical trial or who did not complete a trial because of an adverse event.\nIn addition, provide narrative summaries for serious adverse events.\n\n(5) Describe any information that suggests a substantial change in the incidence of\ncommon, but less serious, adverse events between the new data and the original\napplication data.\n\n(6) Provide updated exposure information for the clinical studies/trials (e.g., number\nof subjects, person time).\n\n(7) Provide a summary of worldwide experience on the safety of this product. Include\nan updated estimate of use for product marketed in other countries.\n\n(8) Provide English translations of current approved foreign labeling not previously\nsubmitted.\n\nOTHER\n\nWithin one year after the date of this letter, you are required to resubmit or take other\nactions available under 21 CFR 314.110. If you do not take one of these actions, we\nmay consider your lack of response a request to withdraw the application under\n\n21 CFR 314.65. You may also request an extension of time in which to resubmit the\napplication.\n\nA resubmission must fully address all the deficiencies listed in this letter and should be\nclearly marked with \"RESUBMISSION\" in large font, bolded type at the beginning of the\ncover letter of the submission. The cover letter should clearly state that you consider\nthis resubmission a complete response to the deficiencies outlined in this letter. A partial\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5825414\n\nNDA 218607\nPage 4\n\nresponse to this letter will not be processed as a resubmission and will not start a new\nreview cycle.\n\nYou may request a meeting or teleconference with us to discuss what steps you need to\ntake before the application may be approved. If you wish to have such a meeting,\nsubmit your meeting request as described in the draft guidance for industry Formal\nMeetings Between the FDA and Sponsors or Applicants of PDUFA Products.\n\nThe product may not be legally marketed until you have been notified in writing that this\napplication is approved.\n\nnih ou have any questions, please contact [in\n\nSincerely,\n{See appended electronic signature page}\n\nCenter for Drug Evaluation and Research\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5825414\n\nSignature Page 1 of 1\n\nThis is a representation of an electronic record that was signed\nelectronically. Following this are manifestations of any and all\nelectronic signatures for this electronic record.\n\n(b) (4)\n\n06/29/2026 01:57:43 PM\n\nReference ID: 5825414\n",
      "application_number": [
        "NDA 218607"
      ],
      "letter_type": "COMPLETE RESPONSE"
    }
  ]
}