{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:pradaxa",
  "owner": "cardio",
  "kind": "product",
  "slug": "pradaxa",
  "name": "Dabigatran (Pradaxa)",
  "aliases": [
    "Pradaxa"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "The Pradaxa brand of dabigatran, whose FDA application names Boehringer Ingelheim. The US Food and Drug Administration approved it in October 2010 to lower the stroke and systemic embolism risk of people with non-valvular atrial fibrillation.",
  "summary_technical": "FDA NDA 022512, approved 2010-10-19 (approval letter), sponsor Boehringer Ingelheim in the openFDA record. The openFDA active ingredient is DABIGATRAN ETEXILATE MESYLATE; this atlas links it to the dabigatran substance. openFDA lists capsules and names Boehringer Ingelheim Pharmaceuticals Inc. as manufacturer, and this record links to the Boehringer Ingelheim organization record. The approval letter covers capsules of 75 mg and 150 mg.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "cardio": {
      "condition-area": [
        "arrhythmias",
        "stroke"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Oral capsules (openFDA product list)",
    "version": "Original approval covered capsules of 75 mg and 150 mg (approval letter); other strengths now on the openFDA list are not described here",
    "intended_use_snapshots": []
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  "content_digest": "d07560e779aad748ed3fcb1971199d515161ebc014e3a6dd08f02f766c37809d",
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
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      "owner": "cardio",
      "subject_entity_id": "cardio:pradaxa",
      "category": "regulatory",
      "statement": "The US Food and Drug Administration approved NDA 022512 for PRADAXA (dabigatran etexilate mesylate) capsules, submitted by Boehringer Ingelheim Pharmaceuticals, Inc., on 19 October 2010. The approval letter covers PRADAXA capsules of 75 mg and 150 mg, with the indication of lowering the stroke and systemic embolism risk of people with non-valvular atrial fibrillation. The openFDA record lists the original submission as approved, with priority review, in the class Type 1 - New Molecular Entity.",
      "context": {
        "id": "cardio:ctx-fda-nda022512-us-approval",
        "label": "United States NDA NDA022512 approval for PRADAXA (dabigatran etexilate mesylate)",
        "recipient": "unknown",
        "population": "People with non-valvular atrial fibrillation (restated from the approval letter). The letter gives no other population details.",
        "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 (they say people with atrial fibrillation and give no age)",
        "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": []
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      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "The approval letter and the openFDA record state the regulatory decision and the indication, not how well the medicine works for any person. The trial evidence is on the dabigatran page (RE-LY). The letter covers the capsules of 75 mg and 150 mg named in it; the openFDA product list for the application now includes other strengths, which are not described here. openFDA data are unvalidated. The approval letter is a cite-only source until the integration owner confirms the terms for its host.",
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      "checked_at": "2026-10-14",
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