Chronic Kidney Disease

• FDA approval · 2015-06-26
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Jardiance (empagliflozin) by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2015-06-12
  FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for ZOMACTON (somatropin) from Ferring Pharmaceuticals, likely to update labeling or expand indicati…

• FDA approval · 2015-06-09
  FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for sevelamer hydrochloride (Renagel) submitted by Sanofi-Aventis U.S. LLC. The approval updates the…

• FDA approval · 2015-06-05
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide from Marlex Pharmaceuticals, Inc., updating the product label.

• FDA approval · 2015-06-05
  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, under Vantive US Healthcare LLC.

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• FDA approval · 2015-05-27
  FDA Approved: PARICALCITOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for PARICALCITOL from Dr. Reddy's Laboratories Limited.

• FDA approval · 2015-05-22
  FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Ferric Citrate from Mylan Pharmaceuticals, expanding the regulatory approval for the product.

• FDA approval · 2015-05-18
  FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application from Mylan Pharmaceuticals Inc. for Ferric Citrate, approving a generic version of the iron-based ph…

• FDA approval · 2015-05-13
  FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)

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

• FDA approval · 2015-02-09
  FDA Approved: DIANEAL LOW CALCIUM WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  FDA approves a supplemental application for Dianeal Low Calcium with Dextrose, a peritoneal dialysis solution manufactured by Vantive US Hea…

• FDA approval · 2015-01-23
  FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk, resulting in an approved supplemental indication/lab…

• FDA approval · 2014-12-08
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

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

• FDA approval · 2014-11-26
  FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Sevelamer Hydrochloride by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-11-26
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Sevelamer carbonate (Renvela), a phosphate binder used to control hyperphosphatemia in chronic k…

• FDA approval · 2014-11-26
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2014-11-18
  FDA Approved: PARICALCITOL — Original Application (West-Ward Pharmaceuticals Corp)

  FDA approved paricalcitol under an original NDA from West-Ward Pharmaceuticals Corp for the management of secondary hyperparathyroidism in a…

• FDA approval · 2014-11-15
  FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Ferric Citrate by Mylan Pharmaceuticals Inc.

• FDA approval · 2014-10-06
  FDA Approved: CALCIUM ACETATE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's calcium acetate under an Original Application (ANDA) as a generic phosphate binder to …

• FDA approval · 2014-09-30
  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 from Vantive US Healthcare…

• FDA approval · 2014-09-30
  FDA Approved: DIANEAL PD-2 WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  FDA approves a supplemental application for DIANEAL PD-2 WITH DEXTROSE, a peritoneal dialysis solution, manufactured by Vantive US Healthcar…

• FDA approval · 2014-09-24
  FDA Approved: FOSRENOL — Original Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved Fosrenol (lanthanum carbonate) through Takeda's original NDA to treat hyperphosphatemia in adults with chronic kidney disea…

• FDA approval · 2014-09-24
  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 · 2014-09-24
  FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)

  The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) from Fresenius Medical Care Renal Therapies Group, LLC.

• FDA approval · 2014-09-05
  FDA Approved: FERRIC CITRATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Ferric Citrate from Mylan as an original application to treat hyperphosphatemia in adults with chronic kidney disease on dialys…

• FDA approval · 2014-08-07
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  The FDA approved a supplemental application for DELFLEX, a dialysis solution from Fresenius Medical Care North America, comprising dextrose …