End-stage Renal Disease

• FDA approval · 2013-04-26
  FDA Approved: DIANEAL PD-2 WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Dianeal PD-2 with Dextrose, a peritoneal dialysis solution, with manufacturing by Vantive US…

• FDA approval · 2013-04-19
  FDA Approved: DIANEAL PD-2 WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Dianeal PD-2 with Dextrose, a peritoneal dialysis solution, submitted by Vantive US Healthca…

• FDA approval · 2013-04-19
  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 solution) submitted by Vantive US Healt…

• FDA approval · 2013-04-19
  FDA Approved: DIANEAL LOW CALCIUM WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Dianeal Low Calcium with Dextrose, a peritoneal dialysis solution, manufactured by Vantive U…

• FDA approval · 2013-04-18
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care de Mexico, S.A. de C.V.)

  FDA approved a supplemental application for DELFLEX, a dialysis solution containing dextrose and electrolytes, manufactured by Fresenius Med…

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• FDA approval · 2013-04-18
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  The FDA approved a supplemental application for DELFLEX, a dialysis solution, submitted by Fresenius Medical Care North America.

• FDA approval · 2013-02-22
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  FDA approved a supplemental application for DELFLEX submitted by Fresenius Medical Care North America, updating its formulation to include d…

• FDA approval · 2013-02-05
  FDA Approved: CALCIUM ACETATE — Original Application (Chartwell RX LLC)

  FDA approves Chartwell RX LLC's calcium acetate as a new generic phosphate binder under an Original Application (ANDA 202420).

• FDA approval · 2013-01-30
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care de Mexico, S.A. de C.V.)

  FDA approved a supplemental application for DELFLEX, a dialysis solution from Fresenius Medical Care de Mexico, S.A. de C.V.

• FDA approval · 2013-01-30
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  FDA approved a supplemental application for DELFLEX, a dialysis solution, from Fresenius Medical Care North America.

• 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 · 2011-04-27
  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 · 2011-03-09
  FDA Approved: EXTRANEAL — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Extraneal (icodextrin) solution submitted by Vantive US Healthcare LLC.

• FDA approval · 2009-09-14
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care de Mexico, S.A. de C.V.)

  FDA issued a supplemental approval for DELFLEX, a multicomponent dialysis solution, manufactured by Fresenius Medical Care de Mexico, S.A. d…

• FDA approval · 2009-09-14
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  The FDA approved a supplemental application for DELFLEX, a dialysate solution, from Fresenius Medical Care North America.

• 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 · 2009-04-07
  FDA Approved: EXTRANEAL — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Extraneal (icodextrin-based peritoneal dialysis solution) submitted by Vantive US Healthcare…

• FDA approval · 2009-01-29
  FDA Approved: EXTRANEAL — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Extraneal. The product is an icodextrin-based peritoneal dialysis solution containing icodex…

• 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 · 2008-10-02
  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 · 2008-05-06
  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 · 2007-08-23
  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 solution from Vantive US Healthcare LLC…