Venous Thromboembolism

• EMA approval · 2026-08-25
  EMA Authorised: Svariya (previously Rivaroxaban Koanaa) (rivaroxaban) — Koanaa Healthcare GmbH

  EMA authorised Svariya (rivaroxaban) for prevention and treatment uses related to thromboembolic conditions; managed by Koanaa Healthcare Gm…

• EMA approval · 2026-07-27
  EMA Authorised: Apixaban Accord (apixaban) — Accord Healthcare S.L.U.

  Authorised status for Apixaban Accord (apixaban) by Accord Healthcare S.L.U. for venous thromboembolism, stroke, and arthroplasty indication…

• EMA approval · 2026-07-16
  EMA Authorised: Inhixa (enoxaparin sodium) — Techdow Pharma Netherlands B.V.

  The EMA has authorised Inhixa (enoxaparin sodium) for Venous Thromboembolism, with Techdow Pharma Netherlands B.V. as the marketing authoriz…

• EMA approval · 2026-04-22
  EMA Authorised: Dabigatran Etexilate Accord (dabigatran etexilate mesilate) — Accord Healthcare S.L.U.

  The EMA authorised the generic dabigatran etexilate mesilate product 'Dabigatran Etexilate Accord' by Accord Healthcare S.L.U. for preventio…

• EMA approval · 2026-04-20
  EMA Authorised: Lixiana (edoxaban tosilate) — Daiichi Sankyo Europe GmbH

  The EMA authorised Lixiana (edoxaban tosilate) from Daiichi Sankyo Europe GmbH for indications related to stroke and venous thromboembolism.

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• EMA approval · 2026-04-20
  EMA Authorised: Roteas (edoxaban tosilate) — Berlin-Chemie AG

  The European Medicines Agency authorised Roteas, a product containing edoxaban, for indications related to stroke prevention and venous thro…

• EMA approval · 2026-04-01
  EMA Authorised: Eliquis (apixaban) — Bristol-Myers Squibb / Pfizer EEIG

  The EMA authorised Eliquis (apixaban) to prevent venous thromboembolism in patients undergoing arthroplasty, with Bristol-Myers Squibb/Pfize…

• EMA approval · 2026-03-13
  EMA Authorised: Pradaxa (dabigatran etexilate mesilate) — Boehringer Ingelheim International GmbH

  EMA has authorised Pradaxa (dabigatran etexilate mesilate) for use in patients undergoing arthroplasty replacement and for prevention of ven…

• EMA approval · 2026-03-05
  EMA Authorised: Inhixa (enoxaparin sodium) — Techdow Pharma Netherlands B.V.

  The EMA authorised Inhixa (enoxaparin sodium) for the prevention and treatment of venous thromboembolism, with Techdow Pharma Netherlands B.…

• EMA approval · 2026-02-24
  EMA Authorised: Apixaban Accord (apixaban) — Accord Healthcare S.L.U.

  The European Medicines Agency authorised Apixaban Accord (apixaban) from Accord Healthcare S.L.U. for indications in venous thromboembolism,…

• EMA approval · 2025-12-17
  EMA Authorised: Rivaroxaban Koanaa (rivaroxaban) — Koanaa Healthcare GmbH

  The European Medicines Agency authorised Koanaa Healthcare GmbH's rivaroxaban product, Koanaa, for indications including venous thromboembol…

• EMA approval · 2025-11-05
  EMA Authorised: Rivaroxaban Viatris (previously Rivaroxaban Mylan) (rivaroxaban) — Viatris Limited

  The EMA authorised Viatris Limited to market rivaroxaban (brand name Rivaroxaban Viatris), expanding access to this anticoagulant as a gener…

• FDA approval · 2025-10-07
  FDA Approved: RIVAROXABAN — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's generic rivaroxaban under an original ANDA, for the same indications as the reference product (e.g., reduc…

• EMA approval · 2025-08-28
  EMA Authorised: Rivaroxaban Accord (rivaroxaban) — Accord Healthcare S.L.U.

  The EMA authorised Accord Healthcare's rivaroxaban product (Rivaroxaban Accord) for multiple indications including acute coronary syndrome, …

• FDA approval · 2025-06-26
  FDA Approved: RIVAROXABAN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' generic rivaroxaban (RIVAROXABAN) under an Original Application, enabling a generic version of the anticoa…

• FDA approval · 2025-05-14
  FDA Approved: RIVAROXABAN — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original ANDA for rivaroxaban, making a generic rivaroxaban available in the U.S. for approved indic…

• FDA approval · 2025-05-14
  FDA Approved: RIVAROXABAN — Original Application (Dr.Reddy's Laboratories, Inc.)

  FDA approved Dr. Reddy's Laboratories' generic rivaroxaban for marketing (ANDA 208534), expanding access to the direct oral anticoagulant. T…

• FDA approval · 2025-01-28
  FDA Approved: DABIGATRAN ETEXILATE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved Dr.Reddys Laboratories Inc for a generic version of dabigatran etexilate under an Original Application, making the product avai…

• EMA approval · 2025-01-21
  EMA Authorised: Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma) (dabigatran etexilate mesilate) — Teva GmbH

  The EMA authorised Teva's dabigatran etexilate mesilate product for prevention of venous thromboembolism, including after arthroplasty (join…

• FDA approval · 2024-12-10
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for Heparin Sodium, updating the product's approval details.

• FDA approval · 2024-10-24
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Pfizer's supplemental application for Heparin Sodium, the anticoagulant. The approval updates the product's labeling/indication…

• EMA approval · 2024-09-12
  EMA Authorised: Xarelto (rivaroxaban) — Bayer AG

  The European Medicines Agency authorised Xarelto (rivaroxaban) for the prevention of venous thromboembolism in patients undergoing arthropla…

• FDA approval · 2023-10-18
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approves a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo, resulting in an update to the drug’s labeling.

• FDA approval · 2022-08-23
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Warfarin sodium submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2022-07-28
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for enoxaparin sodium from Gland Pharma Limited.