{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:ozempic",
  "owner": "cardio",
  "kind": "product",
  "slug": "ozempic",
  "name": "Semaglutide injection for diabetes (Ozempic)",
  "aliases": [
    "Ozempic"
  ],
  "atlases": [
    "cardio"
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  "summary_plain": "A prescription semaglutide injection given once a week. The FDA label record lists it to improve blood sugar control in adults with type 2 diabetes, to lower the risk of major heart and blood-vessel events in adults who also have established cardiovascular disease, and to lower the risk of kidney decline, kidney failure and cardiovascular death in adults who also have chronic kidney disease.",
  "summary_technical": "FDA application NDA209637, applicant listed as NOVO. Original approval on 2017-12-05 (ORIG-1, Type 1 - New Molecular Entity). Dosage form SOLUTION. The label record used for the indications is a repackager copy (A-S Medication Solutions, effective 2026-07-30).",
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  "last_substantive_edit": "2026-10-14",
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  "navigation": {
    "cardio": {
      "system": [
        "metabolism"
      ],
      "condition-area": [
        "diabetes-and-metabolic-disease"
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    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Solution for subcutaneous injection (dosage form SOLUTION on the openFDA record); several strengths.",
    "version": "Not stated in the sources read. The application covers several strengths and presentations.",
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      "category": "regulatory",
      "statement": "The US Food and Drug Administration approved Ozempic (semaglutide injection) on 5 December 2017 under new drug application NDA209637. The Drugs@FDA page lists the original submission as ORIG-1, an approval, classified Type 1 - New Molecular Entity. The openFDA record lists the applicant as NOVO. The label record fetched on 2026-10-14 says Ozempic is a GLP-1 receptor agonist indicated to improve glycemic control in adults with type 2 diabetes, to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults who have both type 2 diabetes and chronic kidney disease. It is dosed once weekly.",
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        "label": "United States FDA original approval of a new drug application (NDA)",
        "recipient": "unknown",
        "population": "Not stated in the FDA application records read. The records give the applicant, the products and the submission history; the label record gives age limits for each indication.",
        "care_setting": "Not stated in the FDA records",
        "geography": "United States (decision by the US Food and Drug Administration)",
        "life_stage_note": "Not stated in the FDA records",
        "life_stage_terms": null,
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
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        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
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      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "An FDA approval is a decision about a medicine, not a finding about how much it helps any person. The date comes from the Drugs@FDA page, which writes it as a month-first slash date. The openFDA record gives the date only as a compact number, so the page is quoted. The indications quoted are those on the label record fetched on 2026-10-14 and may differ from the original 2017 approval, which later supplements changed; the original indication is not in the sources read. openFDA says not to rely on it for decisions about medical care. The label record is a copy listed under the repackager A-S Medication Solutions, not Novo Nordisk; no label record from Novo Nordisk was found by the application-number search.",
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