Chronic Kidney Disease

• FDA approval · 2012-10-31
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Fosrenol (lanthanum carbonate) filed by Takeda Pharmaceuticals America, expanding the product's …

• 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 · 2012-06-28
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

  FDA approved the supplemental application for Zemplar (paricalcitol) from AbbVie Inc.

• FDA approval · 2012-06-01
  FDA Approved: CALCIUM ACETATE — Original Application (Chartwell RX, LLC.)

  FDA approved the original application for calcium acetate (Calcium Acetate) by Chartwell RX, LLC as a generic drug.

• FDA approval · 2012-05-11
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., authorizing a generic version of the diuretic. Thi…

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• FDA approval · 2012-03-27
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2011-11-14
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for hydrochlorothiazide submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2011-09-02
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Fosrenol (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.

• 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 · 2011-06-16
  FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for sevelamer hydrochloride (Sanofi-Aventis U.S. LLC).

• FDA approval · 2011-06-16
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for sevelamer carbonate (Renvela) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2011-04-27
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-04-06
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Zemplar (paricalcitol) filed by AbbVie Inc., approving an update to the product labeling.

• 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 · 2011-02-01
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Zemplar (paricalcitol) submitted by AbbVie.

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for furosemide, a generic diuretic, under the existing ANDA.

• FDA approval · 2010-12-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide filed by Chartwell RX, LLC, authorizing changes under the supplemental NDA. The appro…

• FDA approval · 2010-10-18
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for LASIX (furosemide) from Validus Pharmaceuticals LLC.

• FDA approval · 2010-07-28
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company, authorizing changes to the existing p…

• FDA approval · 2010-06-11
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for ZEMPLAR (paricalcitol) from AbbVie Inc.

• FDA approval · 2010-01-21
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Bumex (bumetanide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2009-11-12
  FDA Approved: SENSIPAR — Supplemental Application (Amgen Inc)

  The FDA approved Amgen's supplemental application for SENSIPAR (cinacalcet hydrochloride), resulting in updated labeling for the product.

• FDA approval · 2009-08-20
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for ZEMPLAR (paricalcitol) submitted by AbbVie.

• FDA approval · 2009-08-12
  FDA Approved: SEVELAMER CARBONATE — Original Application (Sanofi-Aventis U.S. LLC)

  FDA approved Sevelamer carbonate (brand Renvela) via an original NDA to treat hyperphosphatemia in adults with chronic kidney disease on dia…

• 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 …