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  "meta": {
    "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": "03/16/2026",
      "approver_title": "Silver Spring, MD 20993",
      "file_name": "CRL_NDA216442_20260316.pdf",
      "letter_year": "2026",
      "approval_status": "Unapproved",
      "approver_name": "U.S. Food and Drug Administration",
      "approver_center": [],
      "company_rep": "David Noskowitz",
      "company_address": "131 Hartwell Ave., Suite 320\nLexington, MA 02421",
      "company_name": "Aldeyra Therapeutics, Inc.",
      "text": "ADMINISTRATION\n\n( Lg YN U.S. FOOD & DRUG\n\nNDA 216442\nCOMPLETE RESPONSE\n\nAldeyra Therapeutics, Inc.\nAttention: David Noskowitz\n\nRegulatory Affairs Consultant\n131 Hartwell Ave., Suite 320\nLexington, MA 02421\n\nDear David Noskowitz:\n\nPlease refer to your new drug application (NDA)\n\nfor Reproxalap Ophthalmic Solution, ©® .\n\nWe acknowledge receipt of your amendment dated me) , which constituted a\ncomplete response to our oe , action letter. We acknowledge receipt of your\nmajor amendment dated oe , which extended the goal date by three\nmonths.\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\nThere is a lack of substantial evidence consisting of adequate and well-controlled\ninvestigations, as defined in § 314.126, that the drug product will have the effect it\npurports or is represented to have under the conditions of use prescribed,\nrecommended, or suggested in its proposed labeling. The application has 1 failed to\ndemonstrate efficacy in adequate and well controlled studies in\n\nThe inconsistency of study results raises serious concerns about the reliability and\nmeaningfulness of the positive findings. ADX-102-DED-012, ADX-102-DED-019, ADX-\n102-DED-023, ADX-102-DED-030, ADX-102-DED-031 were failed trials. The totality of\nevidence from the completed clinical trials does not support the effectiveness of the\nproduct. We recommend that you explore the common reasons for treatment failure in\nthe multiple failed trials. We also recommend that you attempt to identify populations or\ncertain conditions in which the drug product may be effective.\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\n\nReference ID: 5763508\n\nNDA 216442\nPage 2\n\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\nCARTON AND CONTAINER LABELING\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate.\n\nPROPRIETARY NAME\n\nPlease refer to our correspondence dated, , which addresses the\nproposed proprietary name, I\"). 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\n(b) (4)\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\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 the deficiency 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 deficiency outlined in this letter. A partial\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. The\n\n1 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources\n2 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-\nfinal-rule\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5763508\n\nNDA 216442\nPage 3\n\nproduct may not be legally marketed until you have been notified in writing that this\napplication is approved.\n\nIf you have any questions, please contact ye yyy ys.\n\nSincerely,\n\n{See appended electronic signature page}\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5763508\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\n03/16/2026 12:30:24 PM\n\nReference ID: 5763508\n",
      "application_number": [
        "NDA 216442"
      ],
      "letter_type": "COMPLETE RESPONSE"
    }
  ]
}