Chronic Kidney Disease
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2024-08-27FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) to update the product labeling.
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FDA label_change · 2024-08-16FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Genotropin (somatropin) from Pfizer, resulting in changes to the labeling. The notice reflects t…
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FDA label_change · 2022-10-20FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) filed by AbbVie, resulting in changes to its labeling.
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FDA label_change · 2020-12-04FDA Approved: CINACALCET — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for cinacalcet (Cipla USA Inc.), resulting in changes to CINACALCET's labeling.
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FDA label_change · 2020-09-11FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)
The FDA approved a supplemental application for FERAHEME (ferumoxytol) to update its labeling.
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FDA label_change · 2020-04-30FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for sevelamer hydrochloride (Sanofi) resulting in changes to the product’s labeling.
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FDA label_change · 2020-04-10FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Exelan Pharmaceuticals Inc.)
FDA approved a supplemental application for Sevelamer carbonate from Exelan Pharmaceuticals Inc., resulting in updated labeling.
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FDA label_change · 2019-10-17FDA Approved: PARICALCITOL — Supplemental Application (Accord Healthcare, Inc.)
The FDA approved a supplemental application for paricalcitol from Accord Healthcare, resulting in a label change for this chronic kidney dis…
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FDA label_change · 2017-08-03FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) to update the product labeling.
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FDA label_change · 2017-04-13FDA Approved: ARANESP — Supplemental Application (Amgen, Inc)
FDA approves Amgen's supplemental application for ARANESP (darbepoetin alfa), resulting in a label change for the product.
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FDA label_change · 2016-12-01FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)
The FDA approved a supplemental application for VelTassa (patiromer) submitted by Vifor Pharma, Inc.
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FDA label_change · 2016-11-30FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) to update labeling and/or indications.
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FDA label_change · 2016-01-06FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Farxiga (dapagliflozin), resulting in changes to the product labeling.
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FDA label_change · 2015-10-16FDA Approved: EXTRANEAL — Supplemental Application (Vantive US Healthcare LLC)
FDA approved a supplemental application for Extraneal (icodextrin) to update its labeling, including the formulation ingredients listed as i…
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FDA label_change · 2015-08-27FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate from Mylan Pharmaceuticals, representing a label change to the product.
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FDA label_change · 2015-03-16FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)
FDA approved a supplemental application for FERAHEME (ferumoxytol) to update labeling. The changes may include revised indications, dosing, …
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FDA label_change · 2012-07-11FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for furosemide from Chartwell RX, LLC, resulting in changes to the drug's labeling.
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FDA label_change · 2012-06-05FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)
FDA approved a supplemental application for Feraheme (ferumoxytol) to update the product labeling following AMAG Pharmaceuticals' submission…
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FDA label_change · 2011-06-16FDA 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 to update the product labelin…
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FDA label_change · 2011-04-06FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) from AbbVie, updating its labeling.
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FDA label_change · 2008-06-18FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA overview of AbbVie’s supplemental application for ZEMPLAR (paricalcitol) to update labeling.
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FDA label_change · 2007-10-19FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for sevelamer hydrochloride, updating the labeling for the product.
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FDA label_change · 2007-07-17FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) from AbbVie, resulting in changes to the product labeling. Paricalcitol i…