FDA Approved Drugs for Nephrology

Drugs Approved in 2015

Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 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

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 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

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