Iron Deficiency Anemia

• FDA approval · 2014-06-13
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

  FDA approved a supplemental application for VENOFER (iron sucrose) submitted by Fresenius Medical Care Holdings, Inc.

• FDA approval · 2013-12-23
  FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)

  FDA approved a supplemental application for FERAHEME (ferumoxytol) to modify its labeling for iron replacement therapy in adults with iron d…

• FDA approval · 2013-07-25
  FDA Approved: INJECTAFER — Original Application (American Regent, Inc.)

  FDA approved INJECTAFER (ferric carboxymaltose injection) in an original application. It provides parenteral iron for the treatment of iron …

• FDA approval · 2013-03-29
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

  The FDA approved a supplemental application for VENOFER (iron sucrose) submitted by Fresenius Medical Care Holdings, Inc.

• FDA approval · 2013-02-01
  FDA Approved: FERRLECIT — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for Ferrlecit (sodium ferric gluconate complex) submitted by Sanofi-Aventis U.S. LLC.

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• FDA approval · 2012-09-21
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

  FDA approved a supplemental application for VENOFER (iron sucrose) submitted by Fresenius Medical Care Holdings, Inc.

• FDA approval · 2012-02-28
  FDA Approved: SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for a generic iron replacement product, sodium ferric gluconate complex in sucrose, manufactured by …

• FDA approval · 2011-06-22
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

  The FDA approved a supplemental application for VENOFER (iron sucrose) from Fresenius Medical Care Holdings, Inc., updating the product labe…

• FDA approval · 2011-06-21
  FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for FERAHEME (ferumoxytol) from AMAG Pharmaceuticals.

• FDA approval · 2011-03-31
  FDA Approved: SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic sodium ferric gluconate complex in sucrose (IV iron) under an Original Application (AN…

• FDA approval · 2009-08-12
  FDA Approved: INFED — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for INFED (iron dextran), resulting in changes to the product labeling.

• FDA approval · 2009-06-30
  FDA Approved: FERAHEME — Original Application (AMAG Pharmaceuticals, Inc.)

  The FDA approved Feraheme (ferumoxytol) from AMAG Pharmaceuticals as an original application for the treatment of iron deficiency anemia in …

• FDA approval · 2007-12-03
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

  FDA approved a supplemental application for VENOFER (iron sucrose) submitted by Fresenius Medical Care Holdings, Inc.

• FDA approval · 2007-02-09
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

  The FDA approved a supplemental application for VENOFER (iron sucrose) submitted by Fresenius Medical Care Holdings, Inc.

• FDA approval · 2006-10-02
  FDA Approved: FERRLECIT — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for Ferrlecit (sodium ferric gluconate complex) submitted by Sanofi-Aventis U.S. LLC.