Firecrawl Alexandria

FDA

Name: FDA
Creator: FDA

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

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Which interchangeable biosimilars reference Eylea, and when did each become interchangeable?

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const result = await firecrawl.scrape({
  alexandria: {
    provider: "fda-gov",
    capability: "records/complete_response_letter",
    options: {
      application_number: "BLA 761303",
      letter_date: "2024-03-22",
      submission: "Original 2",
    },
  },
});

2Response example

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{
  "application_numbers": [
    "BLA761303"
  ],
  "application_status": "unapproved",
  "company_name": "Regeneron Pharmaceuticals, Inc.",
  "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.",
  "fda_center": null,
  "fda_offices": [],
  "last_updated": "2026-08-13",
  "letter_date": "2024-03-22",
  "letter_type": "COMPLETE RESPONSE",
  "observed_at_ms": 1793380063190,
  "other_letters": [
    {
      "application_status": "unapproved",
      "letter_date": "2025-07-30",
      "letter_type": "COMPLETE RESPONSE",
      "submissions": []
    },
    {
      "application_status": "unapproved",
      "letter_date": "2024-03-22",
      "letter_type": "COMPLETE RESPONSE",
      "submissions": [
        "Original 1"
      ]
    }
  ],
  "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761303Original2_20240322.pdf",
  "section_headings": [
    "CLINICAL",
    "PRESCRIBING INFORMATION",
    "CARTON AND CONTAINER LABELING",
    "MEDICATION GUIDE",
    "PROPRIETARY NAME",
    "SAFETY UPDATE",
    "ADDITIONAL COMMENTS",
    "PRODUCT QUALITY",
    "OTHER"
  ],
  "signed_by": null,
  "signed_by_title": null,
  "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761303*+OR+application_number%3ABL%5C+761303*%29+AND+letter_date%3A%5B20240322+TO+20240322%5D&limit=10",
  "submissions": [
    "Original 2"
  ],
  "text": "ADMINISTRATION\n\no FN U.S. FOOD & DRUG\n&\n\nBLA 761303/Original 2\nCOMPLETE RESPONSE\n\nRegeneron Pharmaceuticals, Inc.\nAttention: Hsiao-Chi Lo, PhD\nDirector, Regulatory Affairs\n\n777 Old Saw Mill River Road\nTarrytown, NY 10591-6707\n\nDear Dr. Lo:\n\nPlease refer to your biologics license application (BLA) oe\n\n(b) (4)\n\nfor (odronextamab).\n\nWe have administratively designated your application as follows:\n\n(0) (4)\n\nThe subject of this Complete Response letter is for BLA 761303/Original 2.\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\nCLINICAL\n\n(1) The Agency has determined that a confirmatory trial is required to be underway\nfor odronextamab for large B-cell lymphoma (LBCL) prior to approval.’ However,\na confirmatory trial in LBCL with odronextamab is not considered to be\nunderway. oe , you had enrolled |) patients in the dose-finding\nportion of OLYMPIA-3, and a patients have been enrolled in the confirmatory\nportion of the trial. Additionally, the current conduct of OLYMPIA-3 and projected\n\n1 Federal Food, Drug, and Cosmetic Act (FD&C Act) sections 506(c)(2)(A)(i) and (D)\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 2\n\ncompletion date do not provide sufficient assurance of timely completion of the\nrial.\n\nTo support resubmission of the BLA, you must address this deficiency. After\nenrollment and analysis of Part 1 (dose-finding) is completed, we recommend\nhat you request a meeting with the Agency to discuss trial benchmarks (e.g.,\nenrollment goals, site activation, proportion of primary endpoint events accrued,\nrial completion date) to allow measurement of the progress of the trial. You\nshould demonstrate in your submission that your milestones are appropriate and\nhat, prior to approval, you will demonstrate sufficient progress in the conduct of\nhe confirmator… [6,118 more characters]",
  "text_available": true
}

Source: U.S. Food and Drug Administration (FDA): openFDA (including MAUDE device adverse events, PMA, device classification, GUDID without GMDN content, and the UNII substance registry), the Orange Book and Purple Book data files, the Paragraph IV certification list, the novel drug, first generic and cellular and gene therapy approval lists, the orphan drug designation database, and warning letters. Public domain U.S. Government data; use does not imply FDA endorsement. (https://www.fda.gov/about-fda/about-website/website-policies)