Chronic Kidney Disease

• FDA approval · 2009-06-29
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2009-05-04
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2008-12-19
  FDA Approved: DIANEAL LOW CALCIUM WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  FDA approved a supplemental application for Dianeal Low Calcium with Dextrose, a peritoneal dialysis dialysate solution manufactured by Vant…

• FDA approval · 2008-10-23
  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 · 2008-05-09
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for torsemide by Chartwell RX, LLC, updating an approved generic product (ANDA).

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• FDA approval · 2008-05-06
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  The FDA approved a supplemental application for DELFLEX, a dialysate solution containing dextrose and electrolytes, submitted by Fresenius M…

• FDA approval · 2008-04-10
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) from Takeda Pharmaceuticals America, resulting in an approved lab…

• FDA approval · 2008-02-26
  FDA Approved: CALCIUM ACETATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s calcium acetate for use as a phosphate binder in patients with hyperphosphatemia due to chroni…

• 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 · 2007-11-08
  FDA Approved: ARANESP — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for ARANESP (darbepoetin alfa) from Amgen, Inc.

• FDA approval · 2007-10-19
  FDA Approved: SEVELAMER CARBONATE — Original Application (Sanofi-Aventis U.S. LLC)

  FDA approved SEVELAMER CARBONATE (Sanofi-Aventis U.S. LLC) for control of serum phosphate in adults with chronic kidney disease on dialysis.

• FDA approval · 2007-08-14
  FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Sevelamer hydrochloride (Renagel) filed by Sanofi-Aventis U.S. LLC.

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., approving regulatory action on an existing generic…

• 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 · 2006-11-01
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company.

• FDA approval · 2006-10-26
  FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company.

• FDA approval · 2006-09-18
  FDA Approved: FUROSEMIDE — Original Application (Ipca Laboratories Limited)

  FDA approved the Original Application for furosemide from Ipca Laboratories Limited, enabling a generic version of the diuretic to be market…

• FDA approval · 2006-07-03
  FDA Approved: CALCITRIOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Calcitriol from Hikma Pharmaceuticals USA Inc., updating the approval status for this generi…