Nonvalvular Atrial Fibrillation

• 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 · 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 · 2015-01-15
  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…

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• FDA approval · 2012-12-19
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) from Boehringer Ingelheim Pharmaceuticals Inc., to modif…

• FDA approval · 2012-11-02
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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

• FDA approval · 2011-11-09
  FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  FDA approved Boehringer Ingelheim Pharmaceuticals' supplemental application for Pradaxa (dabigatran etexilate mesylate).

• FDA approval · 2011-07-01
  FDA Approved: XARELTO — Original Application (Janssen Pharmaceuticals, Inc.)

  The FDA documents the approval of the original application for Xarelto (rivaroxaban) from Janssen Pharmaceuticals.

• FDA approval · 2010-10-19
  FDA Approved: PRADAXA — Original Application (Boehringer Ingelheim Pharmaceuticals Inc.)

  The FDA approved Pradaxa (dabigatran etexilate mesylate) under an original NDA from Boehringer Ingelheim Pharmaceuticals Inc.