{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:jardiance",
  "owner": "cardio",
  "kind": "product",
  "slug": "jardiance",
  "name": "Empagliflozin (Jardiance)",
  "aliases": [
    "Jardiance",
    "JARDIANCE"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "Jardiance is the brand name of empagliflozin tablets, an SGLT2 inhibitor. The US FDA approved the application on 1 August 2014. The FDA records fetched here do not say what the medicine was approved to treat in 2014, and they do not say which later changes added other uses, including for heart failure. This page records the application and the trials of the medicine are on the empagliflozin page.",
  "summary_technical": "FDA application NDA204629. The openFDA record names BOEHRINGER INGELHEIM as the sponsor and Boehringer Ingelheim Pharmaceuticals, Inc. as a manufacturer name in its openFDA block.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "heart-failure"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Empagliflozin tablets",
    "version": "The openFDA record lists tablets of two strengths. Current labelling was not read.",
    "intended_use_snapshots": []
  },
  "content_digest": "99b22a79cc0bdb3193d1a37b721d3d14cb47a76606e843ec747a9720900f9fc0",
  "review": {
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
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  "claims": [
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      "id": "cardio:claim-fda-nda204629-approval",
      "owner": "cardio",
      "subject_entity_id": "cardio:jardiance",
      "category": "regulatory",
      "statement": "The US Food and Drug Administration approved New Drug Application NDA204629 for JARDIANCE (empagliflozin) tablets on 1 August 2014. The openFDA record lists the original approval as submission ORIG-1, classified as Type 1 - New Molecular Entity, with standard review priority. The openFDA record names BOEHRINGER INGELHEIM as the sponsor of the application.",
      "context": {
        "id": "cardio:ctx-fda-nda204629-us-approval",
        "label": "United States approval record NDA204629 for Jardiance (empagliflozin)",
        "recipient": "unknown",
        "population": "Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.",
        "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,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
        "eligibility": {
          "inclusion": [],
          "exclusion": []
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "This claim records the original approval and the fields the records give. The records fetched carry no indication text for the original approval, so the claim does not say what the medicine was approved to treat then. The openFDA record also lists later submissions, mostly supplements, and the fetched records do not say which of them changed the approved uses, including for heart failure. Current labelling was not read. An approval is not a finding about how well the medicine works. openFDA's own disclaimer says not to rely on it for decisions about medical care.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
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      "jurisdictions": [
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      "jurisdiction_note": "United States",
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      "pathway": "nda",
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      "device_class": null,
      "decision_date": "2014-08-01",
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      {
        "predicate": "manufactured_by",
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      {
        "predicate": "part_of",
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        "clinical_claim_not_fact": false,
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    ],
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  "page_path": "products/jardiance/",
  "context_path": "api/v1/context/cardio--jardiance.md"
}