# Rivaroxaban (Xarelto)

Product · id `cardio:xarelto` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: Xarelto

Browse, condition area: Stroke; Heart rhythm problems  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA drug application NDA202439 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202439&limit=1>
     Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:25:25Z. Source state: Current. Snapshot hash: 22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b.
     How it applies: Quote from the FDA record.
  2. Supports: FDA drug application NDA202439 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202439&limit=1>
     Locator: results\[0\].sponsor\_name. Retrieved 2026-10-14T18:25:25Z. Source state: Current. Snapshot hash: 22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b.
     How it applies: Quote from the FDA record.
  3. Supports: FDA drug application NDA202439 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202439&limit=1>
     Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:25:25Z. Source state: Current. Snapshot hash: 22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b.
     How it applies: Quote from the FDA record.
  4. Supports: FDA drug application NDA202439 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202439&limit=1>
     Locator: results\[0\].submissions\[24\].submission\_status. Retrieved 2026-10-14T18:25:25Z. Source state: Current. Snapshot hash: 22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b.
     How it applies: Quote from the FDA record.
  5. Supports: FDA drug application NDA202439 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202439&limit=1>
     Locator: results\[0\].submissions\[24\].submission\_class\_code\_description. Retrieved 2026-10-14T18:25:25Z. Source state: Current. Snapshot hash: 22e64605b1042d63a4fffebba8173405d66edb4e8b2db5e9a3a1f528b5d7836b.
     How it applies: Quote from the FDA record.
  6. Supports: FDA approval letter for NDA NDA202439 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf>
     Locator: Signature page, date (MM/DD/YYYY). Retrieved 2026-10-14T18:25:33Z. Source state: Current. Snapshot hash: b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b.
     How it applies: Quote from the FDA record.
  7. Supports: FDA approval letter for NDA NDA202439 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf>
     Locator: Page 1, addressee. Retrieved 2026-10-14T18:25:33Z. Source state: Current. Snapshot hash: b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b.
     How it applies: Quote from the FDA record.
  8. Supports: FDA approval letter for NDA NDA202439 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf>
     Locator: Page 1, paragraph 5. Retrieved 2026-10-14T18:25:33Z. Source state: Current. Snapshot hash: b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b.
     How it applies: Quote from the FDA record.
  9. Supports: FDA approval letter for NDA NDA202439 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-11-04.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf>
     Locator: Page 1, indication. Retrieved 2026-10-14T18:25:33Z. Source state: Current. Snapshot hash: b19a65bc215c668aa07493a871bc40fe8e98c9e21911d061a88b9f656ab76c9b.
     How it applies: Quote from the FDA record.
  10. Supports: FDA drug application NDA022406 (openFDA Drugs@FDA record) (Regulator, edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA022406&limit=1>
     Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:43Z. Source state: Current. Snapshot hash: f48b35e3fb5849e9fa38e5084480b3f9d524e337d003d0efbef8ce6911586707.
     How it applies: Quote from the FDA record.
  11. Supports: FDA approval letter for NDA NDA022406 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-07-01.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf>
     Locator: Signature page, date (MM/DD/YYYY). Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 3666667892e6131408db539b197a2423d8fce911d33e1b40d23688bee3b50191.
     How it applies: Quote from the FDA record.
  12. Supports: FDA approval letter for NDA NDA022406 (Regulator, edition Approval letter PDF as fetched on 2026-10-14; the signature page is dated 2011-07-01.) <http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf>
     Locator: Page 1, paragraph 3. Retrieved 2026-10-14T18:25:06Z. Source state: Current. Snapshot hash: 3666667892e6131408db539b197a2423d8fce911d33e1b40d23688bee3b50191.
     How it applies: Quote from the FDA record.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-nda202439`

- Product: Rivaroxaban (Xarelto) (`cardio:xarelto`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2011-11-04
- Product version: Not stated in the FDA record (the letter covers the tablets named in it)
- Pathway: NDA
- Submission: NDA202439
- Indication: To lower the stroke and systemic embolism risk of people with nonvalvular atrial fibrillation (approval letter, restated)
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-nda202439-approval`

## Connected pages

- Active ingredient: Rivaroxaban (`cardio:rivaroxaban`)
- Filed under this front: Medicines (`cardio:front-medicines`)

## Provenance

Content hash: 9484be62229af4b0d43560bf193cb15f80646766f6e1c9bd2443e3e4b43bddd3
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14