Pulmonary Embolism

• FDA approval · 2019-09-26
  FDA Approved: WARFARIN SODIUM — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Warfarin Sodium by Exelan Pharmaceuticals. This action updates the regulatory status of this…

• FDA approval · 2019-09-20
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for JANTOVEN (warfarin sodium) submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-08-23
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) filed by Janssen Pharmaceuticals, resulting in labeling changes to the pro…

• FDA approval · 2019-05-28
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals Inc.'s Heparin Sodium as an Original Application (ANDA 211007), making a generic injectable anticoagul…

• FDA approval · 2019-03-14
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Amphastar Pharmaceuticals, Inc.)

  FDA approved Amphastar Pharmaceuticals' generic enoxaparin sodium injection (ANDA 208600). This marks approval of a generic version of enoxa…

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• FDA approval · 2018-12-20
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Hospira's Heparin Sodium and Dextrose (heparin sodium) product, authorizing changes under the ND…

• FDA approval · 2018-12-14
  FDA Approved: HEPARIN SODIUM — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's original application for generic heparin sodium (ANDA211005).

• FDA approval · 2018-12-11
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a Supplemental Application for enoxaparin sodium from Sanofi-Aventis U.S. LLC to update the product labeling.

• FDA approval · 2018-11-14
  FDA Approved: FONDAPARINUX SODIUM — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approves the Original Application for fondaparinux sodium from Zydus Pharmaceuticals (USA) Inc., a generic anticoagulant.

• FDA approval · 2017-12-26
  FDA Approved: FONDAPARINUX SODIUM — Original Application (Eugia US LLC)

  FDA approved a generic version of fondaparinux sodium (Eugia US LLC) through an Original ANDA, enabling use of this anticoagulant for preven…

• FDA approval · 2017-11-30
  FDA Approved: HEPARIN SODIUM — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for HEPARIN SODIUM (generic) from Mylan Institutional LLC, authorizing marketing of this anticoagulant.…

• FDA approval · 2017-10-20
  FDA Approved: DRAXIMAGE MAA — Supplemental Application (Jubilant DraxImage Inc)

  FDA approves a supplemental application for the DRAXIMAGE MAA kit to prepare Technetium-99m albumin aggregated for lung imaging; kit manufac…

• FDA approval · 2017-09-29
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) by Daiichi Sankyo Inc., resulting in updated labeling.

• FDA approval · 2016-09-15
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo Inc., expanding the drug's regulatory status…

• FDA approval · 2016-04-25
  FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)

  The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo to modify the label, reflecting upda…

• FDA approval · 2016-03-01
  FDA Approved: DRAXIMAGE MAA — Supplemental Application (Jubilant DraxImage Inc)

  FDA approved a supplemental marketing application for the DRAXIMAGE MAA kit, used to prepare technetium-99m macroaggregated albumin for lung…

• FDA approval · 2016-02-18
  FDA Approved: FONDAPARINUX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for fondaparinux sodium from Dr. Reddy's Laboratories Limited, enabling a new generic version of the…

• FDA approval · 2015-11-13
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Heparin Sodium submitted by Fresenius Kabi USA, LLC (NDA 017651). The approval updates labeling …

• FDA approval · 2015-10-26
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2015-09-10
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals, I…

• FDA approval · 2015-08-24
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-08-18
  FDA Approved: HEPARIN SODIUM IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter's Supplemental Application for Heparin Sodium in Sodium Chloride (Heparin Sodium), approving changes to an already-appro…

• FDA approval · 2015-05-11
  FDA Approved: DRAXIMAGE MAA — Supplemental Application (Jubilant DraxImage Inc)

  FDA supplements approval for DRAXIMAGE MAA, a kit for preparing Technetium-99m aggregated albumin. The kit is used to perform lung perfusion…

• FDA approval · 2015-01-15
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals In…

• FDA approval · 2014-06-23
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Italfarmaco SpA)

  FDA approved the original application for ENOXAPARIN SODIUM (enoxaparin sodium) submitted by Italfarmaco SpA under an ANDA. The approval con…