Chronic Kidney Disease

• FDA approval · 2018-10-26
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2018-10-25
  FDA Approved: SEVELAMER CARBONATE FOR ORAL SUSPENSION — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved an original ANDA for Sevelamer carbonate for oral suspension from Dr. Reddy's Laboratories Inc.

• FDA approval · 2018-10-11
  FDA Approved: CINACALCET — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved cinacalcet (Sun Pharmaceutical) via an original application; the generic CINACALCET is approved for secondary hyperparathyroidi…

• FDA approval · 2018-10-09
  FDA Approved: PARICALCITOL — Original Application (Eugia US LLC)

  FDA approved the original ANDA for paricalcitol from Eugia US LLC, a vitamin D receptor activator, for the treatment of secondary hyperparat…

• FDA approval · 2018-08-20
  FDA Approved: PARSABIV — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for Parsabiv (etelcalcetide) from Amgen, updating the product labeling. The action relates to tr…

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• FDA approval · 2018-08-08
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2018-05-15
  FDA Approved: RETACRIT — Original Application (Vifor (International) Inc.)

  The FDA approved Retacrit (epoetin alfa-epbx) under Original Application BLA125545, establishing it as a biosimilar to epoetin alfa. The app…

• FDA approval · 2018-04-25
  FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)

  The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…

• FDA approval · 2018-03-20
  FDA Approved: SEVELAMER CARBONATE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' sevelamer carbonate generic (ANDA200959) for controlling serum phosphorus in adults with chronic k…

• FDA approval · 2018-01-23
  FDA Approved: BUMETANIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Bumetanide under an Original Application for Upsher-Smith Laboratories, establishing a generic version of the loop diuretic.

• FDA approval · 2017-12-22
  FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Feraheme (ferumoxytol) from AMAG Pharmaceuticals, updating its labeling as part of a supplementa…

• FDA approval · 2017-11-28
  FDA Approved: SEVELAMER CARBONATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals’ generic Sevelamer carbonate (Original Application) for the treatment of hyperphosphatemia in adults wit…

• FDA approval · 2017-10-26
  FDA Approved: SEVELAMER CARBONATE — Original Application (Exelan Pharmaceuticals Inc.)

  FDA approved a generic version of sevelamer carbonate (Sevelamer carbonate) from Exelan Pharmaceuticals Inc. for the treatment of hyperphosp…

• FDA approval · 2017-09-29
  FDA Approved: SEVELAMER CARBONATE — Original Application (DR. REDDY'S LABORATORIES LIMITED)

  FDA approved the Sevelamer carbonate original application (ANDA206094) from Dr. Reddy's Laboratories Limited for the treatment of hyperphosp…

• FDA approval · 2017-08-11
  FDA Approved: LANTHANUM CARBONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic lantHanum carbonate under an original ANDA to treat hyperphosphatemia in adults with end-stage r…

• FDA approval · 2017-07-17
  FDA Approved: SEVELAMER CARBONATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for Sevelamer carbonate by Aurobindo Pharma Limited.

• FDA approval · 2017-06-14
  FDA Approved: CALCITRIOL — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' generic calcitriol (1,25-dihydroxyvitamin D3). The approval is an Original Application for this generic…

• FDA approval · 2017-06-13
  FDA Approved: SEVELAMER CARBONATE — Original Application (Aurobindo Pharma Limited)

  FDA approves Sevelamer carbonate as a generic via an Original Application from Aurobindo Pharma Limited.

• FDA approval · 2017-03-09
  FDA Approved: PARICALCITOL — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original ANDA for PARICALCITOL, a generic paricalcitol product for treating secondary hyperparathy…

• FDA approval · 2017-03-01
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca Pharmaceuticals LP. This action updates the drug's …

• FDA approval · 2016-12-14
  FDA Approved: RAYALDEE — Supplemental Application (OPKO Pharmaceuticals LLC)

  FDA approved a supplemental application for RAYALDEE (calcifediol) from OPKO Pharmaceuticals LLC.

• FDA approval · 2016-11-25
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Sevelamer carbonate (Renvela) from Sanofi-Aventis U.S. LLC, updating the product labeling. The c…

• FDA approval · 2016-11-25
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2016-11-09
  FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Ferric Citrate submitted by Mylan Pharmaceuticals Inc., adding regulatory authorization for the …

• FDA approval · 2016-10-18
  FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)

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