FDA Approved Drugs for Nephrology
Drugs Approved in 2017
Parsabiv (etelcalcetide); Amgen;
For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017
Drugs Approved in 2016
Cabometyx (cabozantinib); Exelixis;
For the treatment of advanced renal cell carcinoma, Approved April 2016
Lenvima (lenvatinib); Eisai;
For the treatment of advanced renal cell carcinoma, Approved May 2016
Rayaldee (calcifediol) ; Opko Health;
For the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, Approved June 2016
Drugs Approved in 2015
Envarsus XR (tacrolimus extended-release); Veloxis;
For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015
Opdivo (nivolumab); Bristol-Myers Squibb;
For the treatment of advanced renal cell carcinoma, Approved November 2015
Zurampic (lesinurad); AstraZeneca;
For the treatment of hyperuricemia associated with gout , Approved December 2015
Drugs Approved in 2014
Auryxia (Ferric citrate); Keryx Biopharma;
For the treatment of hyperphosphatemia in patients with chronic kidney disease, Approved September 2014
Harvoni (ledipasvir and sofosbuvir); Gilead;
For the treatment of hepatitis C, Approved October 2014
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie;
For the treatment of genotype 1 chronic hepatitis C virus, Approved December 2014
Drugs Approved in 2013
Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals;
For the treatment of iron deficiency anemia, Approved July 2013
Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals;
For the management of nephropathic cystinosis, Approved May 2013
Drugs Approved in 2012
Afinitor (everolimus); Novartis;
For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012
Inlyta (axitinib); Pfizer;
For the treatment of advanced renal cell carcinoma, Approved January 2012
Myrbetriq (mirabegron); Astellas Pharma US, Inc;
For the treatment of overactive bladder, Approved June 2012
Omontys (peginesatide); Affymax;
For the treatment of anemia due to chronic kidney disease, Approved March 2012
Stendra (avanafil); Vivus;
For the treatment of erectile dysfunction, Approved April 2012
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals;
For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012
Voraxaze (glucarpidase); BTG International;
For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
Drugs Approved in 2011
Anturol (oxybutynin) Gel; Antares Pharma;
For the treatment of overactive bladder, Approved December 2011
Nulojix (belatacept); Bristol-Myers Squibb;
For the prevention of organ rejection following kidney transplant, Approved June 2011
Drugs Approved in 2010
Carbaglu (carglumic acid); Recordati;
For the treatment of hyperammonemia, Approved March 2010
Jalyn (dutasteride + tamsulosin); GlaxoSmithKline;
For the treatment of benign prostatic hyperplasia, Approved June 2010
Jevtana (cabazitaxel); sanofi aventis;
For the treatment of prostate cancer, Approved June 2010
Provenge (sipuleucel-T); Dendreon;
For the treatment of hormone refractory prostate cancer, Approved May 2010
Xifaxan (rifaximin); Salix Pharmaceuticals;
For the treatment of hepatic encephalopathy, Approved March 2010
Zortress (everolimus); Novartis;
For the prevention of organ rejection following kidney transplant, Approved May 2010
Drugs Approved in 2009
Afinitor (everolimus); Novartis;
For the treatment of renal cell carcinoma, Approved March 2009
Avastin (bevacizumab); Genentech;
For the treatment of renal cell carcinoma, Approved July 2009
Feraheme (ferumoxytol); AMAG;
For the treatment of iron deficiency anemia associated with chronic kidney disease, Approved June 2009
Gelnique (oxybutynin chloride); Watson Pharmaceuticals;
For the treatment of overactive bladder, Approved January 2009
Votrient (pazopanib); GlaxoSmithKline;
For the treatment of renal cell carcinoma, Approved October of 2009
Drugs Approved in 2008
Degarelix (degarelix for injection); Ferring Pharmaceuticals;
For the treatment of prostate cancer, Approved December of 2008
Toviaz (fesoterodine fumarate); Pfizer;
For the treatment of overactive bladder, Approved October 2008
Drugs Approved in 2007
Doribax (doripenem); Johnson & Johnson;
For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007
Mircera (methoxy polyethylene glycol-epoetin beta); Roche;
For the treatment of anemia associated with chronic renal failure, Approved November 2007
Renvela (sevelamer carbonate); Genzyme;
For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007
Soliris (eculizumab); Alexion;
For the treatment of PNH, aHUS and generalized Myasthenia Gravis , Approved March 2007
Torisel (temsirolimus); Wyeth;
For the treatment of renal cell carcinoma, Approved May 2007
Drugs Approved in 2005
Vaprisol (conivaptan); Astellas Pharma US, Inc;
For the treatment of euvolemic hyponatremia, Approved December 2005
Drugs Approved in 2004
Fosrenol, lanthanum carbonate; Shire Pharmaceuticals;
For the treatment of hyperphosphatemia related to kidney dysfunction, Approved October, 2004
Sanctura (trospium chloride); Indevus Pharmaceuticals;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, Approved May, 2004
Sensipar (cinacalcet); Amgen;
For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients, Approved March 2004
Vesicare (solifenacin succinate); Yamanouchi, GlaxoSmithKline;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, Approved November, 2004
Drugs Approved in 2003
Fabrazyme (agalsidase beta); Genzyme;
For the treatment of Fabry disease in adult patients, Approved April 2003
Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003
UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis;
For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Drugs Approved in 2002
Eligard (leuprolide acetate); Atrix Laboratories;
For the palliative treatment of advanced prostate cancer, Approved January 2002
Mesnex; Bristol-Myers Squibb, Baxter Healthcare;
Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide), Approved March 2002
Drugs Approved in 2001
Dutasteride; GlaxoSmithKline;
For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001
Invanz; Merck;
Once-daily injectable treatment for bacterial infections, Approved November 2001
PhosLo; Braintree Laboratories;
Oral capsules and gelcaps for the control of hyperphosphatemia in end stage renal failure, Approved April 2001
Trelstar LA (triptorelin pamoate); Debiopharm;
Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001
Drugs Approved in 2000
Cefazolin and Dextrose USP; B Braun Medical;
Respiratory tract infections, Approved July 2000
Detrol LA (tolterodine tartrate); Pharmacia & Upjohn;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency, Approved December 2000
Hectorol (Doxercalciferol) Injection; Bone Care International;
To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, Approved April 2000
Rapamune (sirolimus) Tablets; Wyeth;
For treatment of kidney rejection, Approved August 2000
Renagel (sevelamer hydrochloride); GelTex Pharmaceuticals;
For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD), Approved July 2000
Renagel (sevelamer hydrochloride); Genzyme;
For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000
Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates;
For the palliative treatment of advanced prostate cancer, Approved June 2000
Venofer (iron sucrose injection); Luitpold Pharmaceuticals;
For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000
Viadur (leuprolide acetate implant); Alza;
For pain relief in men with advanced prostate cancer, Approved March 2000
Drugs Approved in 1999
Ditropan XL (oxybutynin chloride); Alza;
Treatment for overactive bladder, Approved June 1999
Levaquin; RW Johnson;
Treatment for urinary tract infection, Approved July 1999
Tequin; Bristol-Myers Squibb;
Tequin (Injectable and Tablet), December, 1999
Drugs Approved in 1998
Detrol (tolterodine tartrate); Pharmacia & Upjohn;
Treatment for an overactive bladder, Approved March 1998
Ditropan XL (oxybutynin chloride); Alza;
Treatment for and Overactive Bladder, Approved December 1998
Proscar; Merck;
Treatment for complication relating to benign prostatic hyperplasia (BPH), Approved April 1998
RenaGelRenagel (sevelamer hydrochloride); GelTex Pharmaceuticals;
Treatment for Renal Disease, Approved November 1998
Simulect; Novartis;
Treatment for acute organ transplant rejection, Approved May 1998
Zemplar; Abbott Laboratories;
Treatment of secondary hyperparathyroidism associated with chronic renal failure, Approved April 1998
Drugs Approved in 1997
EDEX; Schwarz Pharma;
Treatment for erectile dysfunction, Approved June 1997
FLOMAX; Boehringer Ingelheim;
Treatment for benign prostatic hypertrophy (BPH), Approved October 1997
Interstim Continence Control Therapy; Medtronic;
Treatment for incontinence, Approved September 1997
Prograf; Fujisawa Healthcare;
Treatment for the prevention of kidney transplant rejection, Approved April 1997
Zenapax; Roche;
Treatment to prevent rejection of kidney transplants, Approved December 1997
Drugs Approved in 1996
Cipro (ciprofloxacin HCl); Bayer;
Treatment for cystitis, Approved April 1996
Elmiron (pentosan polysulfate sodium); IVAX;
Treatment for interstitial cystitis, Approved October 1996
Eulexin (flutamide); Schering-Plough;
Treatment for prostate cancer, Approved June 1996
Gemzar (gemcitabine HCL); Eli Lilly;
Treatment for pancreatic cancer, Approved May 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories;
Treatment for advanced prostate cancer, Approved January 1996
Monurol; Forest Laboratories;
Treatment for uncomplicated urinary tract infection, Approved December 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Seprafilm; Genzyme;
Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca;
Treatment for advanced prostate cancer, Approved January 1996
Drugs Approved in 1995
Caverject (alprostadil); Upjohn;
Treatment for impotence, Approved on July 6, 1995
