{ "release_id": "5dcd9b263fe17744", "id": "cardio:xarelto", "owner": "cardio", "kind": "product", "slug": "xarelto", "name": "Rivaroxaban (Xarelto)", "aliases": [ "Xarelto" ], "atlases": [ "cardio" ], "summary_plain": "The Xarelto brand of rivaroxaban, whose openFDA sponsor name is Janssen. The US Food and Drug Administration approved it in November 2011 to lower the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation. Its first approval, in July 2011, was for preventing blood clots after hip or knee replacement surgery.", "summary_technical": "FDA NDA 202439 (the atrial fibrillation indication, approved 2011-11-04, consolidated with the original application after approval) and NDA 022406 (the original application, approved 2011-07-01 for prevention of venous clots (deep vein thrombosis, pulmonary embolism) after hip or knee replacement surgery). Sponsor Janssen Pharms in the openFDA records. openFDA lists tablets. The openFDA record of the original application names Janssen Pharmaceuticals, Inc. as manufacturer, and this page links no company record. The regulatory decision on this page is for the atrial fibrillation indication.", "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 tablets (openFDA product list)", "version": "Not stated in the FDA records for the atrial fibrillation approval; the letters name the tablets they cover", "intended_use_snapshots": [] }, "content_digest": "9484be62229af4b0d43560bf193cb15f80646766f6e1c9bd2443e3e4b43bddd3", "review": { "content_digest": "9484be62229af4b0d43560bf193cb15f80646766f6e1c9bd2443e3e4b43bddd3", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-fda-nda202439-approval", "owner": "cardio", "subject_entity_id": "cardio:xarelto", "category": "regulatory", "statement": "The US Food and Drug Administration approved NDA 202439 for XARELTO (rivaroxaban) on 4 November 2011. The letter is addressed to Janssen Pharmaceuticals, Inc., and openFDA names JANSSEN PHARMS as sponsor. The approval letter states the indication as lowering the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation. The openFDA record lists the submission as approved, in the class Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval. The original Xarelto application, NDA 022406, was approved on 1 July 2011 for a different use: its approval letter covers preventing venous clots (deep vein thrombosis, pulmonary embolism) after hip or knee replacement surgery.", "context": { "id": "cardio:ctx-fda-nda202439-us-approval", "label": "United States NDA NDA202439 approval for XARELTO (rivaroxaban)", "recipient": "unknown", "population": "People with nonvalvular 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": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "This claim records the atrial fibrillation indication, which FDA approved under NDA 202439. The original application, NDA 022406, covered a different indication, so a reader should not treat 1 July 2011 as the date of the atrial fibrillation approval. The approval letters state decisions and indications, not how well the medicine works. The trial evidence is on the rivaroxaban page (ROCKET AF). Later supplements are not described here. openFDA data are unvalidated. The approval letters are cite-only sources until the integration owner confirms the terms for their host.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].application_number", "applicability_note": "Quote from the FDA record.", "snapshot": { "id": "cardio:openfda-drugsfda-nda202439-2026-10-14", "retrieved_at": "2026-10-14T18:25:25Z", "content_hash": "22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda202439", "source_type": "regulator", "title": "FDA drug application NDA202439 (openFDA Drugs@FDA record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202439&limit=1", "identifiers": [ { "scheme": "fda-nda", "value": "NDA202439", "normalized_value": "NDA202439", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). 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