Chronic Kidney Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-07-30FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Humatrope (somatropin) from Eli Lilly and Company.
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FDA approval · 2014-06-24FDA Approved: PARICALCITOL — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved the original application for paricalcitol from Dr. Reddy's Laboratories Limited, enabling a generic version of the drug. This m…
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FDA approval · 2014-04-24FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)
FDA approved a supplemental application for DELFLEX, a dialysis solution consisting of dextrose and electrolytes, produced by Fresenius Medi…
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FDA approval · 2014-04-23FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care de Mexico, S.A. de C.V.)
FDA approved a supplemental application for DELFLEX, a dialysate solution from Fresenius Medical Care de Mexico, S.A. de C.V., updating the …
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FDA approval · 2014-04-23FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)
FDA approved a supplemental application for DELFLEX dialysis solution from Fresenius Medical Care North America.
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FDA approval · 2014-04-17FDA Approved: ARANESP — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for ARANESP (darbepoetin alfa) from Amgen.
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FDA approval · 2014-03-27FDA Approved: PARICALCITOL — Original Application (Bionpharma Inc.)
FDA approved Bionpharma Inc.'s original application for paricalcitol, a generic paricalcitol product. This approval supports the use of pari…
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FDA approval · 2014-01-24FDA 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 · 2014-01-24FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)
FDA approved a supplemental application for DELFLEX, a dialysate solution, submitted by Fresenius Medical Care North America.
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FDA approval · 2014-01-13FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)
The FDA approved a supplemental NDA for DELFLEX from Fresenius Medical Care North America. This action represents an update to the product's…
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FDA approval · 2013-12-23FDA Approved: FERAHEME — Supplemental Application (AMAG Pharmaceuticals, Inc.)
FDA approved a supplemental application for FERAHEME (ferumoxytol) to modify its labeling for iron replacement therapy in adults with iron d…
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FDA approval · 2013-11-27FDA Approved: VELPHORO — Original Application (Fresenius Medical Care Renal Therapies Group, LLC)
FDA approved Velphoro (sucroferric oxyhydroxide) under an original NDA for the treatment of hyperphosphatemia in adults with chronic kidney …
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FDA approval · 2013-10-17FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) submitted by AbbVie Inc., indicating an approved update to its labeling/i…
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FDA approval · 2013-08-15FDA 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. It is formulated wit…
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FDA approval · 2013-07-22FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Zemplar (paricalcitol) from AbbVie Inc.
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FDA approval · 2013-05-24FDA Approved: CALCITRIOL — Original Application (BIONPHARMA INC.)
FDA approved the original ANDA application for Calcitriol from BIONPHARMA INC., a generic version of the active vitamin D3 analog.
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FDA approval · 2013-05-15FDA Approved: CALCITRIOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for CALCITRIOL (calcitriol) from Sun Pharmaceutical Industries, Inc., updating the product’s reg…
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FDA approval · 2013-04-26FDA Approved: EXTRANEAL — Supplemental Application (Vantive US Healthcare LLC)
FDA approved a supplemental application for Extraneal (icodextrin) submitted by Vantive US Healthcare LLC.
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FDA approval · 2013-04-18FDA 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 · 2013-04-18FDA 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.
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FDA approval · 2013-04-04FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Omnitrope (somatropin) from Sandoz Inc, potentially expanding or updating the product’s labe…
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FDA approval · 2013-02-07FDA Approved: CALCIUM ACETATE — Original Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s original application for Calcium Acetate (generic calcium acetate).
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FDA approval · 2013-02-05FDA 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).
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FDA approval · 2013-02-01FDA Approved: FERRLECIT — Supplemental Application (sanofi-aventis U.S. LLC)
The FDA approved a supplemental application for Ferrlecit (sodium ferric gluconate complex) submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2013-01-30FDA 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.