{
  "release_id": "73130c34862e2d06",
  "id": "cardio:entresto",
  "owner": "cardio",
  "kind": "product",
  "slug": "entresto",
  "name": "Sacubitril/valsartan (Entresto)",
  "aliases": [
    "Entresto",
    "ENTRESTO"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "Entresto is the brand name of sacubitril and valsartan tablets, a combination medicine. The US FDA approved the application on 7 July 2015, with priority review. The FDA records fetched here do not say what the medicine was approved to treat in 2015. The trial that compared the combination with enalapril is on the sacubitril/valsartan page.",
  "summary_technical": "FDA application NDA207620. The openFDA record names NOVARTIS PHARMS CORP as the sponsor and lists three tablet strengths of sacubitril and valsartan. The openFDA record names Novartis Pharmaceuticals Corporation as a manufacturer, and this record links to the Novartis organization record.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
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  "navigation": {
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      "system": [
        "heart"
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      "condition-area": [
        "heart-failure"
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    }
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  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Sacubitril and valsartan tablets",
    "version": "The openFDA record lists tablets of three strengths. Current labelling was not read.",
    "intended_use_snapshots": []
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
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      "id": "cardio:claim-fda-nda207620-approval",
      "owner": "cardio",
      "subject_entity_id": "cardio:entresto",
      "category": "regulatory",
      "statement": "The US Food and Drug Administration approved New Drug Application NDA207620 for ENTRESTO (sacubitril and valsartan) tablets on 7 July 2015. The openFDA record lists the original approval as submission ORIG-1, classified as a new molecular entity (Type 1) and a new combination (Type 4), with priority review. The openFDA record names NOVARTIS PHARMS CORP as the sponsor of the application.",
      "context": {
        "id": "cardio:ctx-fda-nda207620-us-approval",
        "label": "United States approval record NDA207620 for Entresto (sacubitril and valsartan)",
        "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,
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        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
        "eligibility": {
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          "exclusion": []
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      "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",
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