Atrial Fibrillation

• FDA approval · 2014-03-31
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-03-19
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental NDA for MULTAQ (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-03-06
  FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XARELTO (rivaroxaban) submitted by Janssen Pharmaceuticals, Inc. This action approves changes re…

• FDA approval · 2014-01-30
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for MULTAQ (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-12-06
  FDA Approved: TIKOSYN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Tikosyn (dofetilide) from Pfizer Laboratories Div Pfizer Inc.

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• FDA approval · 2013-05-31
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride submitted by Chartwell RX, LLC. This marks an approval of a supplement …

• FDA approval · 2013-05-31
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc., approving a change under …

• FDA approval · 2013-05-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited, enabling its generic use.

• FDA approval · 2013-05-16
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc.

• FDA approval · 2013-04-29
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) submitted by Baxter Healthcare Company.

• FDA approval · 2013-03-27
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA posted a supplemental approval application for MULTAQ (dronedarone) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2012-12-07
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic diltiazem hydrochloride (ANDA 202463). The product is indicated for the management of hypertensi…

• FDA approval · 2012-11-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc. for an already authorized product.

• FDA approval · 2012-09-07
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) filed by Sanofi-Aventis U.S. LLC. The approval updates the drug's labeling …

• FDA approval · 2012-08-24
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental abbreviated new drug application for diltiazem hydrochloride from Sun Pharmaceutical, a generic calcium channel …

• FDA approval · 2012-08-13
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2012-06-13
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2012-04-27
  FDA Approved: DIGOXIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Digoxin submitted by Sandoz Inc.

• FDA approval · 2012-03-27
  FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Jantoven (warfarin sodium) submitted by Upsher-Smith Laboratories.

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s supplemental application for propranolol hydrochloride, indicating the generic product's supplemental filing h…

• FDA approval · 2012-01-25
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) filed by Sanofi-Aventis U.S. LLC. The drug is the brand Multaq with generic…

• FDA approval · 2012-01-11
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for sotalol hydrochloride, confirming approval of a generic product. …

• FDA approval · 2011-12-30
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin (DIGOXIN) from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2011-12-12
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) from Baxter Healthcare Company.

• FDA approval · 2011-11-29
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Verapamil Hydrochloride from Chartwell RX, LLC.