Chronic Kidney Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-10-07FDA Approved: PARICALCITOL — Original Application (MARKSANS PHARMA LIMITED)
The FDA has approved an original application for a generic paricalcitol from Marksans Pharma Limited. Paricalcitol is a vitamin D analog use…
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FDA approval · 2016-08-16FDA Approved: DIANEAL PD-2 WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)
FDA approved a supplemental application for Dianeal PD-2 with Dextrose, a peritoneal dialysis solution, submitted by Vantive US Healthcare L…
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FDA approval · 2016-08-16FDA 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 manufactured by Vantive US Hea…
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FDA approval · 2016-06-17FDA Approved: RAYALDEE — Original Application (OPKO Pharmaceuticals LLC)
The FDA approved RAYALDEE (calcifediol) from OPKO Pharmaceuticals as a new drug for adults with stage 3–4 chronic kidney disease and hypocal…
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FDA approval · 2016-06-13FDA Approved: VENOFER — Supplemental Application (Fresenius Medical Care Holdings, Inc.)
The FDA approved a supplemental application for VENOFER (iron sucrose) from Fresenius Medical Care Holdings, Inc., resulting in changes to i…
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FDA approval · 2016-05-27FDA 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.
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FDA approval · 2016-03-24FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care de Mexico, S.A. de C.V.)
FDA approves a supplemental application for DELFLEX, a dialysis solution from Fresenius Medical Care de Mexico, S.A. de C.V., describing its…
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FDA approval · 2016-03-09FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for Sevelamer Hydrochloride submitted by Sanofi-Aventis U.S. LLC. This action constitutes a supp…
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FDA approval · 2016-03-09FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer carbonate from Sanofi-Aventis U.S. LLC.
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FDA approval · 2016-03-09FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for sevelamer carbonate, resulting in updated labeling for the product.
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FDA approval · 2016-03-02FDA 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., resulting in chan…
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FDA approval · 2016-02-26FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) from Genentech, Inc., updating/expanding the product’s approv…
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FDA approval · 2016-02-24FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2016-02-24FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2016-02-04FDA Approved: PARICALCITOL — Original Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s paricalcitol under its original application NDA207174 for the treatment of secondary hyperparathyroid…
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FDA approval · 2016-01-14FDA Approved: PARICALCITOL — Original Application (Aurobindo Pharma Limited)
The FDA approved the original application (ANDA) for paricalcitol from Aurobindo Pharma Limited. This generic paricalcitol is used to treat …
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FDA approval · 2016-01-13FDA Approved: PARICALCITOL — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal's original application for generic paricalcitol (PARICALCITOL), a vitamin D analog used to treat secondary hyperparathyr…
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FDA approval · 2016-01-12FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)
FDA approves a supplemental application for Jardiance (empagliflozin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.
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FDA approval · 2015-10-26FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)
FDA approved a supplemental application for FERAHEME (ferumoxytol) by AMAG Pharmaceuticals, Inc. The action likely involves labeling or indi…
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FDA approval · 2015-10-26FDA Approved: CALCIUM ACETATE — Original Application (Westminster Pharmaceuticals, LLC)
The FDA approved the Original Application for calcium acetate from Westminster Pharmaceuticals, LLC, adding a generic calcium acetate produc…
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FDA approval · 2015-09-01FDA Approved: DIANEAL PD-2 WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)
FDA approved a supplemental application for Dianeal PD-2 with Dextrose, a peritoneal dialysis solution, from Vantive US Healthcare LLC.
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FDA approval · 2015-08-18FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
The FDA approved AbbVie’s supplemental application for ZEMPLAR (paricalcitol). The action updates the labeling and/or indications for this p…
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FDA approval · 2015-08-04FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Ferric Citrate filed by Mylan Pharmaceuticals, authorizing continued or expanded use of this…
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FDA approval · 2015-07-27FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)
The FDA approved a supplemental application for FERAHEME (ferumoxytol) filed by AMAG Pharmaceuticals, updating the labeling per the approved…
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FDA approval · 2015-06-29FDA Approved: CALCIUM ACETATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a generic calcium acetate under an Original Application (ANDA 202315) from Heritage Pharmaceuticals (d/b/a Avet) to treat h…