Cardiovascular Atlas
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Rivaroxaban (Xarelto)

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.

Also called Xarelto

  • Product
  • In this atlas

Overview

Technical summary

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.

Product details

Type
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 sources

No intended-use source is recorded.

Claims and evidence

Context United States NDA NDA202439 approval for XARELTO (rivaroxaban)

Recipient
Recipient not specified
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
Not stated in the FDA records (they say people with atrial fibrillation and give no age)
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    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.

    Applies to Recipient not specified
    • People with nonvalvular atrial fibrillation (restated from the approval letter). The letter gives no other population details.
    • Not stated in the FDA records
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA records (they say people with atrial fibrillation and give no age)
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (12)

    1. Supports FDA drug application NDA202439 (openFDA Drugs@FDA record)

      Regulator · 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. · NDA: NDA202439

      Locator
      results[0].application_number
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b
      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). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA202439.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA drug application NDA202439 (openFDA Drugs@FDA record)

      Regulator · 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. · NDA: NDA202439

      Locator
      results[0].sponsor_name
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b
      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). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA202439.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA drug application NDA202439 (openFDA Drugs@FDA record)

      Regulator · 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. · NDA: NDA202439

      Locator
      results[0].products[0].brand_name
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b
      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). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA202439.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA drug application NDA202439 (openFDA Drugs@FDA record)

      Regulator · 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. · NDA: NDA202439

      Locator
      results[0].submissions[24].submission_status
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b
      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). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA202439.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA drug application NDA202439 (openFDA Drugs@FDA record)

      Regulator · 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. · NDA: NDA202439

      Locator
      results[0].submissions[24].submission_class_code_description
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b
      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). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA202439.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA approval letter for NDA NDA202439

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.

      Locator
      Signature page, date (MM/DD/YYYY)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2011-11-04
      Source state
      Current
      Snapshot hash
      b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202439.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    7. Supports FDA approval letter for NDA NDA202439

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.

      Locator
      Page 1, addressee
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2011-11-04
      Source state
      Current
      Snapshot hash
      b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202439.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    8. Supports FDA approval letter for NDA NDA202439

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.

      Locator
      Page 1, paragraph 5
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2011-11-04
      Source state
      Current
      Snapshot hash
      b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202439.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    9. Supports FDA approval letter for NDA NDA202439

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.

      Locator
      Page 1, indication
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2011-11-04
      Source state
      Current
      Snapshot hash
      b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA202439.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    10. Supports FDA drug application NDA022406 (openFDA Drugs@FDA record)

      Regulator · 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. · NDA: NDA022406

      Locator
      results[0].application_number
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f48b35e3fb5849e9fa38e5084480b3f9d524e337d003d0efbef8ce6911586707
      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). The raw record is committed at research/snapshots/cf-openfda-drugsfda-NDA022406.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    11. Supports FDA approval letter for NDA NDA022406

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-07-01.

      Locator
      Signature page, date (MM/DD/YYYY)
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2011-07-01
      Source state
      Current
      Snapshot hash
      3666667892e6131408db539b197a2423d8fce911d33e1b40d23688bee3b50191
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022406.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    12. Supports FDA approval letter for NDA NDA022406

      Regulator · U.S. Food and Drug Administration · Edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-07-01.

      Locator
      Page 1, paragraph 3
      How it applies
      Quote from the FDA record.
      Retrieved
      Source effective date
      2011-07-01
      Source state
      Current
      Snapshot hash
      3666667892e6131408db539b197a2423d8fce911d33e1b40d23688bee3b50191
      Reuse basis
      FDA approval letter hosted on accessdata.fda.gov, fetched as cf-fda-letter-NDA022406.pdf. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This document is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

Authorization

Regulatory decision: Rivaroxaban (Xarelto)

Applies to Recipient not specified
  • People with nonvalvular atrial fibrillation (restated from the approval letter). The letter gives no other population details.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records (they say people with atrial fibrillation and give no age)
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
NDA
Submission
NDA202439
Jurisdictions
United States; note: United States
Product version
Not stated in the FDA record (the letter covers the tablets named in it)
Indication
To lower the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation (approval letter, restated)
Basis
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.

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.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:xarelto
Content hash
9484be62229af4b0d43560bf193cb15f80646766f6e1c9bd2443e3e4b43bddd3